A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors

NCT05981703
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
217
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Lead sponsor
BeOne Medicines
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Start date
2023-09-21
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Number of sites
28
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Summary
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.
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Short title
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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Official title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-09-30
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First posted
2023-08-08
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Registry last updated
2026-06-03
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Primary completion date
2027-09-30
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Start date
2023-09-21
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Participants
217
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Participant count basis
Estimated
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Planned participants
217
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Protocol amendments
3
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Number of sites
28
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
BeOne Medicines
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05981703
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ClinicalTrials.gov ID
NCT05981703
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808

    Timeframe: Approximately 1 month

    MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

  3. Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808

    Timeframe: Approximately 1 month

    RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.

  4. Phase 1b: Overall Response Rate (ORR)

    Timeframe: Approximately 6 months

    ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  1. Phase 1a: ORR

    Timeframe: Approximately 6 months

    ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.

  2. Phase 1a and 1b: Duration of Response (DOR)

    Timeframe: Approximately 9 months

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.

  3. Phase 1a and 1b: Disease Control Rate (DCR)

    Timeframe: Approximately 6 months

    DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.

  4. Phase 1a and 1b: Clinical Benefit Rate (CBR)

    Timeframe: Approximately 6 months

    CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.

  5. Phase 1b: Progression Free Survival (PFS)

    Timeframe: Approximately 9 months

    PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.

  6. Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808

    Timeframe: Approximately 1 month

  7. Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808

    Timeframe: Approximately 6 months

  8. Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808

    Timeframe: Approximately 1 month

    Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.

  9. Phase 1a: Half-life (t1/2) for BGB-26808

    Timeframe: Approximately 1 month

  10. Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808

    Timeframe: Approximately 2 months

  11. Phase 1a: Apparent clearance (CL/F) for BGB-26808

    Timeframe: Approximately 1 month

  12. Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808

    Timeframe: Approximately 1 month

  13. Phase 1a: Accumulation ratio for BGB-26808

    Timeframe: Approximately 2 months

  14. Phase 1b: Plasma concentrations of BGB-26808

    Timeframe: Approximately 2 months

  15. Phase 1b: Number of Participants with AEs and SAEs

    Timeframe: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

    Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
  4. Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
  5. ≥ 1 measurable lesion per RECIST v1.1.
  6. Able to provide an archived tumor tissue sample.
  7. Adequate organ function.
  8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.
  9. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.

  1. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
  3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
  4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse
  6. Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  7. 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(s).
  8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
  9. Uncontrolled diabetes.
  10. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility
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  • City of Hope National Medical CenterDuarte, United StatesRecruiting
  • University of Southern California Norris ComprehensiveLos Angeles, United StatesRecruiting
  • Yale University Yale Cancer CenterNew Haven, United StatesRecruiting
  • Sylvester Cancer Center, University of MiamiMiami, United StatesRecruiting
  • University of Michigan Health SystemAnn Arbor, United StatesRecruiting
  • John Theurer Cancer Center Hackensack University Medical CenterHackensack, United StatesRecruiting
  • Icahn School of Medicine At Mount SinaiNew York, United StatesRecruiting
  • Providence Portland Medical CenterPortland, United StatesRecruiting
  • The University of Texas Md Anderson Cancer CenterHouston, United StatesRecruiting
  • Southside Cancer CareMiranda, AustraliaCompleted
  • Macquarie UniversityNorth Ryde, AustraliaRecruiting
  • Icon Cancer Centre Kurralta ParkKurralta Park, AustraliaRecruiting
  • Linear Clinical ResearchNedlands, AustraliaRecruiting
  • The First Affiliated Hospital of Anhui Medical Universitygaoxin BranchHefei, ChinaRecruiting
  • Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
  • Hubei Cancer HospitalWuhan, ChinaRecruiting
  • Tongji Hospital,Tongji Medical College of Hustsino French New City BranchWuhan, ChinaRecruiting
  • The First Hospital of China Medical University Hunnan BranchShenyang, ChinaRecruiting
  • Jining No1 Peoples Hospital West BranchJining, ChinaRecruiting
  • Yantai Yuhuangding HospitalYantai, ChinaRecruiting
  • Shanghai East Hospital Branch HospitalShanghai, ChinaRecruiting
  • Shanghai Pulmonary HospitalShanghai, ChinaCompleted
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalChengdu, ChinaRecruiting
  • Hangzhou First Peoples HospitalHangzhou, ChinaRecruiting
  • Taizhou Hospital of Zhejiang Province (East)Taizhou, ChinaCompleted

And 3 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • CTR20240210
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)