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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/NCT04649385
Registration number
NCT04649385
Ethics application status
Date submitted
25/11/2020
Date registered
2/12/2020
Date last updated
9/05/2024
Titles & IDs
Public title
BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors
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Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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Secondary ID [1]
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CTR20212721
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Secondary ID [2]
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BGB-A317-15025-101
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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:
Advanced Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-15025
Treatment: Drugs - Tislelizumab
Experimental: Phase 1a: Dose Escalation - Part A: Participants will receive once daily of BGB-15025 monotherapy in sequential cohorts of approximately 7 increasing doses
Part B: Participants will receive once daily of BGB-15025 in sequential cohorts plus 200mg tislelizumab on day 1 of each 21-day cycle (combination therapy )
Experimental: Phase 1b: Dose Expansion - Phase 1b dose expansion will begin based upon the recommended doses for expansion (RDFE) for BGB-15025 alone or in combination with tislelizumab, and with or without chemotherapy as determined from Phase 1a
Treatment: Drugs: BGB-15025
Administered orally once or twice daily (QD or BID)
Treatment: Drugs: Tislelizumab
Administered 200 mg intravenous (IV) 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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Phase 1a: Number of participants with dose limiting toxicities (DLTs)
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Assessment method [1]
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Participants will be considered evaluable for DLTs if they 1) received = 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.
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Timepoint [1]
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Up to 3 Years
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Primary outcome [2]
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Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [2]
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Timepoint [2]
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Up to 4 Years
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Primary outcome [3]
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Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [3]
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Timepoint [3]
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Up to 4 years
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Primary outcome [4]
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The maximum tolerated dose (MTD) of BGB-15025
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Assessment method [4]
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The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
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Timepoint [4]
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Up to 3 Years
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Primary outcome [5]
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Recommended Doses for Expansion (RDFE) of BGB-15025 monotherapy
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Assessment method [5]
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The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
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Timepoint [5]
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Up to 3 years
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Primary outcome [6]
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RDFE of BGB-15025 in combination with tislelizumab
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Assessment method [6]
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The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
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Timepoint [6]
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Up to 3 years
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Primary outcome [7]
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Phase 1b: Overall Response Rate (ORR) as assessed by the investigator
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Assessment method [7]
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Timepoint [7]
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Up to 2 years
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Secondary outcome [1]
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Phase 1a: Overall Response Rate (ORR) as assessed by the investigator
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Assessment method [1]
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Duration Of Response (DOR) as assessed by the investigator
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Assessment method [2]
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Disease Control Rate (DCR) as assessed by the investigator
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Assessment method [3]
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-15025
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Assessment method [4]
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Timepoint [4]
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Predose up to 8 hours postdose
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Secondary outcome [5]
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Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-15025
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Assessment method [5]
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Timepoint [5]
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Predose up to 8 hours postdose
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Secondary outcome [6]
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Phase 1a: Time to maximum plasma concentration (Tmax) of BGB-15025
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Assessment method [6]
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Timepoint [6]
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Predose up to 8 hours postdose
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Secondary outcome [7]
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Phase 1a: Half-life of (t1/2) of BGB-15025
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Assessment method [7]
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Timepoint [7]
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Predose up to 8 hours postdose
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Secondary outcome [8]
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Phase 1a: Area under the concentration-time curve (AUC) of BGB-15025
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Assessment method [8]
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Timepoint [8]
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Predose up to 8 hours postdose
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Secondary outcome [9]
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Phase 1a: Apparent clearance (CL/F) of BGB-15025
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Assessment method [9]
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Timepoint [9]
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Predose up to 8 hours postdose
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Secondary outcome [10]
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Phase 1a: Apparent volume of distribution (Vz/F) of BGB-15025
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Assessment method [10]
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Timepoint [10]
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Predose up to 8 hours postdose
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Secondary outcome [11]
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Phase 1a: Accumulation Ratio for Cmax of BGB-15025
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Assessment method [11]
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Timepoint [11]
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Predose up to 8 hours postdose
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Secondary outcome [12]
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Phase 1a: Accumulation Ratio for AUC of BGB-15025
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Assessment method [12]
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Timepoint [12]
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Predose up to 8 hours postdose
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Secondary outcome [13]
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Phase 1a: Metabolite to parent ratio for BGB-15025 and its metabolite
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Assessment method [13]
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Timepoint [13]
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Predose up to 8 hours postdose
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Secondary outcome [14]
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Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [14]
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Timepoint [14]
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Up to 3 years
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Secondary outcome [15]
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Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [15]
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Timepoint [15]
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Up to 3 years
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Secondary outcome [16]
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Phase 1b: Plasma Concentrations of BGB-15025
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Assessment method [16]
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Timepoint [16]
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Predose up to 8 hours postdose
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Secondary outcome [17]
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Phase 1b: Plasma Concentrations of the metabolite
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Assessment method [17]
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Timepoint [17]
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Predose up to 8 hours postdose
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Secondary outcome [18]
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Phase 1b: Number of participants with dose limiting toxicities (DLTs)
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Assessment method [18]
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Participants will be considered evaluable for DLTs if they 1) received = 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.
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Timepoint [18]
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Up to 1 year
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Eligibility
Key inclusion criteria
Key
1. Phase 1a (dose escalation): Participants with histologically or cytologically
confirmed advanced, metastatic, and unresectable solid tumors who have previously
received standard systemic therapy or for whom treatment is not available, not
tolerated or refused, and who have not received prior therapy targeting HPK1
2. Phase 1b (dose expansion): Participant with histologically or cytologically confirmed
advanced, metastatic, and unresectable solid tumors, including non-small cell lung
cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid
tumors may be included) who have progressed following systemic anticancer therapies or
have no prior systemic treatment for advanced disease
3. At least 1 measurable lesion as defined per RECIST 1.1.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
5. Adequate organ function as indicated by the following laboratory values up to first
dose of study treatment: Hemoglobin= 90 g/L, Absolute neutrophil count = 1.5 x 109/L ,
Serum total bilirubin = 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome ),
AST and ALT= 2.5 x ULN
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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. Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
3. Any active malignancy = 2 years before the first dose of study treatment except for
the specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent
4. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication = 14 days
before the first dose of study treatment
5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung
diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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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
4/03/2021
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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
1/03/2025
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Actual
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Sample size
Target
330
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
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Ashford Cancer Centre Research Northeast - Windsor Gardens
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Recruitment hospital [3]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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Linear Clinical Research - Nedlands
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Recruitment hospital [5]
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One Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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5087 - Windsor Gardens
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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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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Texas
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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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Virginia
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Country [3]
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China
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State/province [3]
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Heilongjiang
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Country [4]
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China
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State/province [4]
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Henan
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Country [5]
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China
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State/province [5]
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Shanghai
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Country [6]
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China
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State/province [6]
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Sichuan
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Country [7]
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China
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State/province [7]
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Tianjin
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Country [8]
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China
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State/province [8]
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Zhejiang
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Country [9]
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Korea, Republic of
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State/province [9]
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Gyeonggido
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Country [10]
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Korea, Republic of
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State/province [10]
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Seoul Teugbyeolsi
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Country [11]
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New Zealand
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State/province [11]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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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 objective of this study is to assess the safety and tolerability of BGB-15025
alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD)
or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone
and in combination with tislelizumab in participants with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04649385
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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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BeiGene
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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/NCT04649385
Download to PDF