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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06194877
Registration number
NCT06194877
Ethics application status
Date submitted
22/12/2023
Date registered
8/01/2024
Date last updated
6/06/2024
Titles & IDs
Public title
A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
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Scientific title
A Phase 1b, Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 With Panitumumab in Patients With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
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Secondary ID [1]
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BGB-3245-EGFR-001
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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:
Colorectal Cancer
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Pancreatic Ductal Cancer
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Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
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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 - BGB-3245
Treatment: Drugs - Panitumumab
Experimental: Part 1: Dose Finding Part - Participants with advanced or metastatic CRC and with known mutation status and tumor harboring an oncogenic mutation of BRAF, KRAS, or NRAS and with documented disease progression by RECIST during or after at least 1 line of prior therapy will be enrolled into 4 planned sequentially run cohorts. Participants will receive escalating doses of BGB-3245 in combination with panitumumab to establish the MTD and RP2D by assessing the safety, tolerability, preliminary antitumor activity, and pharmacokinetics (PK) for the combination of BGB-3245 with panitumumab.
Experimental: Part 2: Dose Expansion Part, Group 1 - Participants with advanced or metastatic CRC that harbors KRAS or NRAS mutations who have been treated and had documented disease progression by RECIST criteria during or after at least 1 line of prior therapy. Participants will receive the RP2D of BGB-3245 in combination with panitumumab to further evaluate the safety, PK, and assess the preliminary antitumor activity of the RP2D of the BGB-3245 and panitumumab combination.
Experimental: Part 2: Dose Expansion Part, Group 2 - Participants with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) that harbors KRAS mutations who have been treated and had documented disease progression by RECIST criteria during or after at least 1 line of prior therapy. Participants will receive the RP2D of BGB-3245 in combination with panitumumab to further evaluate the safety, PK, and assess the preliminary antitumor activity of the RP2D of the BGB-3245 and panitumumab combination.
Treatment: Drugs: BGB-3245
Oral capsule
Treatment: Drugs: Panitumumab
Intravenous (IV) infusion via an infusion pump
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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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Part 1: Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [1]
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Timepoint [1]
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Up to approximately 2 years
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Primary outcome [2]
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Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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Timepoint [2]
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Up to approximately 2 years
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Primary outcome [3]
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Part 1: Number of Participants with Adverse Events of Special Interest (AESIs)
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2 years
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Primary outcome [4]
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Part 1: Number of Participants with Interruptions to Dosing with BGB-3245
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Assessment method [4]
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Timepoint [4]
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Up to approximately 2 years
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Primary outcome [5]
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Part 1: Number of Participants with Reductions in Dosing with BGB-3245
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2 years
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Primary outcome [6]
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Part 1: MTD of BGB-3245
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 years
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Primary outcome [7]
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Part 1: RP2D of BGB-3245
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2 years
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Primary outcome [8]
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Part 2: ORR as Assessed by Initial Investigator Review
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Assessment method [8]
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Timepoint [8]
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Up to approximately 2 years
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Secondary outcome [1]
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Part 1 and 2: Plasma Concentrations of BGB-3245 and Any Relevant Metabolites
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Assessment method [1]
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Timepoint [1]
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Day 1 of each 28 day cycle (up to approximately 2 years)
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Secondary outcome [2]
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Part 1: ORR as Assessed by Investigator Review using RECIST v1.1
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Assessment method [2]
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Timepoint [2]
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Up to approximately 2 years
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Secondary outcome [3]
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Part 2: ORR as Assessed by Central Review
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Part 1 and 2: Duration of Response (DoR)
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Assessment method [4]
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Part 1 and 2: Disease Control Rate (DCR)
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Part 1 and 2: Progression Free Survival (PFS)
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Part 2: Number of Participants with SAEs
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2 years
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Secondary outcome [8]
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Part 2: Number of Participants with TEAEs
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Assessment method [8]
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Timepoint [8]
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Up to approximately 2 years
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Secondary outcome [9]
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Part 2: Number of Participants with AESIs
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Assessment method [9]
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Timepoint [9]
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Up to approximately 2 years
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Secondary outcome [10]
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Part 2: Number of Participants with Interruptions to Dosing with BGB-3245
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Assessment method [10]
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Timepoint [10]
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Up to approximately 2 years
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Secondary outcome [11]
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Part 2: Number of Participants with Reductions in Dosing with BGB-3245
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Assessment method [11]
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Timepoint [11]
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Up to approximately 2 years
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Eligibility
Key inclusion criteria
Key
1. Participants with histologically confirmed advanced or metastatic solid tumors who
have had documented disease progression by RECIST criteria during or after at least 1
prior line of systemic anticancer therapies in the representative population or are
unable to receive standard of care therapy(ies) as noted by local guidelines.
2. Part 1 (Dose Finding): Participants with CRC with a known mutation status by local
testing and tumor harboring an oncogenic mutation of BRAF, KRAS, or NRAS in the
archival tumor sample or fresh tumor biopsy.
3. Part 2 (Dose Expansion): Participants must have a known mutation status by local
testing and meet one of the following criteria according to the group they are
enrolled into: Group 1: Participants with CRC that harbors KRAS or NRAS mutations in
the archival tumor sample or fresh tumor biopsy. Group 2: Participants with PDAC that
harbors KRAS mutations in the archival tumor sample or fresh tumor biopsy.
4. Participants must provide archival tumor tissue or a fresh tumor biopsy for
retrospective mutation status analysis.
5. Participants must have radiologically measurable disease as defined per RECIST v1.1 at
screening.
6. Eastern Cooperative Oncology Group performance status of =1 at screening.
7. Adequate hematologic and organ function, as indicated by defined laboratory values,
prior to Cycle 1 Day 1.
8. Adequate cardiac 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
1. Participants receiving cancer therapy (chemotherapy or other systemic anticancer
therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1.
2. Active infection requiring systemic treatment at the start of the study treatment.
3. Clinically significant cardiovascular disease and / or events within 6 months of
signing the informed consent form.
4. Participants with toxicities that have not recovered to Grade =1 or stabilized and
those Grade 2 toxicities listed as permitted in other eligibility criteria.
5. Participants with a history of pneumonitis or interstitial lung disease.
6. Participants with immune-related toxicities that have not resolved with appropriate
management.
7. History or presence of gastrointestinal disease or other condition known to interfere
with the absorption of drugs.
8. History of ulcerative colitis or Crohn's disease or protracted and ongoing
immune-mediated diarrhea from prior checkpoint inhibitor use.
9. History of corneal perforation, keratitis, or severe dry eye.
10. Current evidence of symptomatic central nervous system metastases, leptomeningeal
carcinomatosis, or untreated spinal cord compression.
11. Any active malignancy =3 years before Cycle 1 Day 1 except for the specific cancer
under investigation in this study and any localized or noninvasive cancer that has
been treated curatively.
12. Known hypersensitivity to rapidly accelerated fibrosarcoma (RAF) inhibitors,
anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, or their
excipients.
13. Any known history of Grade =3 toxicity lasting >14 days from another RAF, mitogen
activated protein kinase, extracellular signal-regulated kinase, or anti-EGFR antibody
inhibitor requiring discontinuation of treatment from these drugs.
14. Receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or
inducer =14 days (or 5 half-lives, whichever is longer) before Cycle 1 Day 1 and until
completion of dosing with BGB-3245 for at least 5 half-lives.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply. Summary of key criteria
provided.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
18/04/2024
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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
24/05/2027
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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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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2145 - Westmead
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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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North Carolina
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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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Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MapKure, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of Part 1 of this study are to:
- Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in
participants with advanced or metastatic colorectal cancer (CRC) with a known mutation
status and tumor harboring an oncogenic mutation of v-Raf murine sarcoma viral oncogene
homolog B; B-RAF proto-oncogene, serine/threonine kinase (BRAF), Kirsten rat sarcoma
viral oncogene homolog (KRAS), or neuroblastoma RAS viral oncogene homolog (NRAS) with
documented disease progression during or after at least 1 line of prior therapy.
- Determine the maximum tolerated dose (MTD) of BGB-3245 in combination with panitumumab
and the recommended phase 2 dose (RP2D) of the combination.
The primary objective of Part 2 of this study is to determine the objective response rate
(ORR) as assessed by initial investigator review using Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 with BGB-3245 and panitumumab combination treatment at the RP2D.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06194877
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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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MapKure
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Address
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Country
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Phone
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1-877-828-5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06194877
Download to PDF