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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05743036
Registration number
NCT05743036
Ethics application status
Date submitted
26/01/2023
Date registered
24/02/2023
Titles & IDs
Public title
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
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Scientific title
A Phase 1/2, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer
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Secondary ID [1]
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Z0011001
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Secondary ID [2]
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ZN-c3-016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ZN-c3
Treatment: Drugs - Encorafenib
Treatment: Drugs - Cetuximab
Experimental: Dose Escalation - Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
Experimental: Dose Expansion - Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab
Treatment: Drugs: ZN-c3
ZN-c3 tablet by mouth, in combination with encorafenib
Treatment: Drugs: Encorafenib
Encorafenib capsule by mouth, in combination with ZN-c3
Treatment: Drugs: Cetuximab
Infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLTs defined as treatment-related AEs occurring within the first 29 days after the start of any study treatment that in the opinion of the investigator cannot be reasonably attributed to the participant's underlying disease, concomitant medications, or pre-existing conditions.
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Timepoint [1]
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From Lead-in Day -1 to Cycle 1 Day 28
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Primary outcome [2]
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Dose Expansion Phase - Objective response rate (ORR)
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Assessment method [2]
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ORR defined as the proportion of participants who achieves a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator per RECIST Version 1.1.
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Timepoint [2]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [1]
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Dose Escalation Phase - Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
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Assessment method [1]
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Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
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Timepoint [1]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [2]
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Proportion of participants with dose interruptions due to AEs in Dose Escalation Phase
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Assessment method [2]
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Timepoint [2]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [3]
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Proportion of participants with dose modifications due to AEs in Dose Escalation Phase
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Assessment method [3]
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Timepoint [3]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [4]
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Proportion of participants with discontinuations due to AEs in Dose Escalation Phase
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Assessment method [4]
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Timepoint [4]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [5]
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Dose Escalation Phase - Objective response rate (ORR)
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Assessment method [5]
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ORR defined as the proportion of participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST Version 1.1.
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Timepoint [5]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [6]
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Dose Escalation Phase - Duration of Response (DOR)
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Assessment method [6]
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DOR defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
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Timepoint [6]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [7]
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Dose Escalation Phase - Progression Free Survival (PFS)
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Assessment method [7]
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PFS defined as the time from the first dose to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
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Timepoint [7]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [8]
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Dose Escalation Phase - Disease Control Rate (DCR)
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Assessment method [8]
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DCR defined as the proportion of participants with BOR of CR, PR, or stable disease (SD), per RECIST version 1.1.
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Timepoint [8]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [9]
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Dose Escalation Phase - Time to Response (TTR)
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Assessment method [9]
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TTR defined as the time from first dose to first radiographic evidence of response (CR or PR) per RECIST version 1.1.
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Timepoint [9]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [10]
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Dose Escalation - ZN-c3 plasma exposure: AUC
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Assessment method [10]
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Timepoint [10]
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From lead in day -1 visit through Cycle 1 Day 15
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Secondary outcome [11]
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Dose Escalation - ZN-c3 plasma exposure: Cmax
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Assessment method [11]
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Timepoint [11]
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From lead in day -1 visit through Cycle 1 Day 15
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Secondary outcome [12]
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Dose Escalation - ZN-c3 plasma exposure: Tmax
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Assessment method [12]
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Timepoint [12]
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From lead in day -1 visit through Cycle 1 Day 15
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Secondary outcome [13]
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Dose Escalation - Encorafenib plasma exposure: AUC
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Assessment method [13]
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Timepoint [13]
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From lead in day -1 visit through Cycle 1 Day 15
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Secondary outcome [14]
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Dose Escalation - Encorafenib plasma exposure: Cmax
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Assessment method [14]
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Timepoint [14]
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From lead in day -1 visit through Cycle 1 Day 15
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Secondary outcome [15]
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Dose Escalation - Encorafenib plasma exposure: Tmax
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Assessment method [15]
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Timepoint [15]
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From lead in day -1 visit through Cycle 1 Day 15
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Secondary outcome [16]
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Dose Expansion Phase - Duration of Response (DOR)
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Assessment method [16]
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DOR defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
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Timepoint [16]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [17]
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Dose Expansion Phase - Progression Free Survival (PFS)
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Assessment method [17]
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PFS defined as the time from the first dose to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
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Timepoint [17]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [18]
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Dose Expansion Phase - Disease Control Rate (DCR)
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Assessment method [18]
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DCR defined as the proportion of participants with BOR of CR, PR, or stable disease (SD), per RECIST version 1.1.
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Timepoint [18]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [19]
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Dose Expansion Phase - Time to Response (TTR)
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Assessment method [19]
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TTR defined as the time from first dose to first radiographic evidence of response (CR or PR) per RECIST version 1.1.
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Timepoint [19]
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From first dose of any study intervention every 8 weeks during treatment, up to 12 months
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Secondary outcome [20]
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Dose Expansion Phase - Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
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Assessment method [20]
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Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
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Timepoint [20]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [21]
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Proportion of participants with dose interruptions due to AEs in Dose Expansion Phase
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Assessment method [21]
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Timepoint [21]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [22]
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Proportion of participants with dose modifications due to AEs in Dose Expansion Phase
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Assessment method [22]
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Timepoint [22]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [23]
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Proportion of participants with discontinuations due to AEs in Dose Expansion Phase
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Assessment method [23]
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Timepoint [23]
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From first dose of any study intervention through 28 days after the last dose of any study intervention
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Secondary outcome [24]
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Dose Expansion - ZN-c3 in combination with combination with E+C plasma exposure: AUC
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Assessment method [24]
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Timepoint [24]
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Lead in day 7
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Secondary outcome [25]
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Dose Expansion - ZN-c3 in combination with combination with E+C plasma exposure: Cmax
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Assessment method [25]
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Timepoint [25]
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Lead in day 7
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Secondary outcome [26]
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Dose Expansion - ZN-c3 in combination with combination with E+C plasma exposure: Tmax
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Assessment method [26]
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Timepoint [26]
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Day 7
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Secondary outcome [27]
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Dose Expansion - Encorafenib in combination with ZN-c3 and cetuximab plasma exposure: AUC
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Assessment method [27]
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Timepoint [27]
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Cycle 1 Day 15
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Secondary outcome [28]
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Dose Expansion - Encorafenib in combination with ZN-c3 and cetuximab plasma exposure: Cmax
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Assessment method [28]
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Timepoint [28]
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Cycle 1 Day 15
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Secondary outcome [29]
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Dose Expansion - Encorafenib in combination with ZN-c3 and cetuximab plasma exposure: Tmax
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Assessment method [29]
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Timepoint [29]
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Cycle 1 Day 15
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Secondary outcome [30]
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Dose Expansion - ZN-c3 plasma exposure: AUC
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Assessment method [30]
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Timepoint [30]
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Cycle 1 Day 15
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Secondary outcome [31]
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Dose Expansion - ZN-c3 plasma exposure: Cmax
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Assessment method [31]
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Timepoint [31]
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Cycle 1 Day 15
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Secondary outcome [32]
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Tumor tissue BRAF V600E mutational status
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Assessment method [32]
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Timepoint [32]
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From lead in day 1 visit through the last dose of any study intervention, up to 12 months
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.
* Documented evidence of a BRAF V600E mutation in tumor tissue or blood
* Presence of measurable disease per RECIST version 1.1 guidelines.
* Disease progression after 1 or 2 previous systemic regimens for metastatic disease
* Adequate bone marrow function
* Adequate hepatic and renal function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Documented clinical disease progression or radiographic disease progression during the screening period
* Leptomeningeal disease.
* Symptomatic brain metastasis.
* Presence of acute or chronic pancreatitis.
* Unable to swallow, retain, and absorb oral medications.
* Clinically significant cardiovascular diseases
* Evidence of active noninfectious pneumonitis.
* Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions
* Participants with known positivity for HIV
* Active hepatitis B or hepatitis C infection
* Concurrent or previous other malignancy within 2 years of study entry
* Has had an allogeneic tissue/solid organ transplant
* Pregnant or females of childbearing potential who have a positive ß-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/09/2026
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Actual
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Sample size
Target
82
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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5011 - Woodville South
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Kansas
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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Germany
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State/province [4]
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Bayern
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Country [5]
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Germany
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State/province [5]
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Hessen
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Country [6]
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Germany
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State/province [6]
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Berlin
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Country [7]
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Hungary
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State/province [7]
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Budapest
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Country [8]
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Hungary
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State/province [8]
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Gyöngyös
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Country [9]
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Italy
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State/province [9]
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Campania
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Country [10]
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Italy
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State/province [10]
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Foggia
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Country [11]
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Italy
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State/province [11]
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Veneto
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Country [12]
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Italy
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State/province [12]
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Milano
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Country [13]
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Poland
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State/province [13]
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Malopolskie
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Country [14]
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Poland
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State/province [14]
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Mazowieckie
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Country [15]
0
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Poland
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State/province [15]
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Opolskie
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Country [16]
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Spain
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State/province [16]
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Cataluna
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Country [17]
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Spain
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State/province [17]
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Cordoba
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Country [18]
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Spain
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State/province [18]
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Valenciana, Comunitat
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Country [19]
0
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Spain
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State/province [19]
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Barcelona
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Country [20]
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Spain
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State/province [20]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Pfizer
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Address [1]
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one or two treatment regimens.
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Trial website
https://clinicaltrials.gov/study/NCT05743036
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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K-Group Beta, Inc. a subsidiary of Zentalis Pharmaceuticals
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Address
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Country
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0
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Phone
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(212) 433-3791
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05743036