Brief Title: Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab

• Status: Recruiting
• Trial end date: 2025-04-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD), recommended Phase 2 dose(RP2D),safety & tolerability of BGB-10188: as monotherapy in participants with mature B-cell malignancies; oin combination with zanubrutinib in participants with relapse/refractory follicular lymphoma (R/R FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL); and in combination with tislelizumab in participants with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Zanubrutinib

Criteria

Key Inclusion Criteria:

Part A, B and C

1. Confirmed diagnosis of one of the following:

• Part A: R/R CLL/SLL, MZL, FL, MCL

• Part B: R/R FL, MCL, or DLBCL

• Part C: R/R FL, MCL, or DLBCL

2. Patients with MZL, FL, MCL, or DLBCL must have at least one bi- dimensionally measurable nodal lesion >1.5 cm in longest diameter or extranodal lesion that is > 1cm in longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Lugano Classification.

Part D and E

3. Part D: Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for which treatment is not available or not tolerated. Enrollment will be limited to patients with advanced solid tumors for which there is clinical evidence of response to T-cell based immuno-oncology agents (eg, anti PD-1, non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC], head and neck squamous cell cancer, hepatocellular carcinoma, gastric or gastroesophageal junction carcinoma, nasopharyngeal carcinoma, renal cell carcinoma, cervical cancer, triple-negative breast cancer, ovarian cancer, endometrial carcinoma, esophageal cancer, melanoma, urothelial carcinoma or patient with confirmed microsatellite instability-high [MSI-H] or mismatch repair deficient [dMMR] solid tumor, etc). Enrollment of tumor types beyond above situations requires sponsor's approval.

4. Part E: Patients with NSCLC or metastatic melanoma that has progressed from PD 1/PD-L1 antibody treatment or patients with SCLC with no prior PD 1/PD-L1 antibody treatment.

5. Part D: Patient must have at least 1 evaluable lesion (either measurable or non-measurable) as defined by RECIST v1.1.

Key Exclusion Criteria:

Part A, B and C

1. History of allogeneic stem-cell transplantation in Part A, Part B, and Part C

Part A, B, C, D and E

2. Prior exposure to PI3K inhibitor.

3. Any approved anticancer therapy, including hormonal therapy, or any investigational agent or participation in another clinical study with therapeutic intent within 14 days before first dose.

4. Treatment with systemic immune-stimulatory agents (including, but not limited to, interferons and interleukin-2) within 2 weeks or 5 half-lives of the drug, whichever is later, before first dose.

5. Known human immunodeficiency virus (HIV) infection, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:

• HBsAg (+), or

• HBcAb (+) and HBV DNA detected, or

• Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable

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