A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid TumorSolid Tumor
- Registration Number
- NCT05981703
- Lead Sponsor
- BeiGene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria:<br><br> 1. Able to provide a signed and dated written informed consent prior to any<br> study-specific procedures, sampling, or data collection.<br><br> 2. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.<br><br> 3. Participants with histologically or cytologically confirmed advanced, metastatic,<br> and unresectable solid tumors that are immune-sensitive who have been previously<br> treated.<br><br> 4. = 1 measurable lesion per RECIST v1.1.<br><br> 5. Able to provide an archived tumor tissue sample.<br><br> 6. Adequate organ function.<br><br> 7. Females of childbearing potential must be willing to use a highly effective method<br> of birth control for the duration of the study, and for = 90 days after the last<br> dose of BGB-26808 or for = 120 days after the last dose of tislelizumab.<br><br> 8. Nonsterile males must be willing to use a highly effective method of birth control<br> for the duration of the study treatment period and for = 90 days after the last dose<br> of BGB-26808 or for = 120 days after the last dose of tislelizumab.<br><br>Exclusion Criteria:<br><br> 1. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent<br> drainage or medical intervention.<br><br> 2. Clinically significant bleeding from the gastrointestinal tract within 28 days<br> before the first dose of study treatment(s).<br><br> 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.<br><br> 4. Active autoimmune diseases or history of autoimmune diseases that may relapse<br><br> 5. Any malignancy = 3 years before the first dose of study treatment(s) except for the<br> specific cancer under investigation in this study and any locally recurring cancer<br> that has been treated with curative intent (eg, resected basal or squamous cell skin<br> cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).<br><br> 6. Any condition that required systemic treatment with either corticosteroids (> 10 mg<br> daily of prednisone or equivalent) or other immunosuppressive medication = 14 days<br> before the first dose of study treatment(s).<br><br> 7. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled<br> lung diseases including pulmonary fibrosis, acute lung diseases.<br><br> 8. Uncontrolled diabetes.<br><br> 9. Infection (including tuberculosis infection) requiring systemic (oral or<br> intravenous) antibacterial, antifungal, or antiviral therapy = 14 days before the<br> first dose of study treatment(s).<br><br>Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs);Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808;Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808;Phase 1b: Overall Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method Phase 1a: ORR;Phase 1a and 1b: Duration of Response (DOR);Phase 1a and 1b: Disease Control Rate (DCR);Phase 1a and 1b: Clinical Benefit Rate (CBR);Phase 1b: Progression Free Survival (PFS);Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808;Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808;Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808;Phase 1a: Half-life (t1/2) for BGB-26808;Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808;Phase 1a: Apparent clearance (CL/F) for BGB-26808;Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808;Phase 1a: Accumulation ratio for BGB-26808;Phase 1b: Plasma concentrations of BGB-26808;Phase 1b: Number of Participants with AEs and SAEs