Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04282018 |
Recruitment Status :
Recruiting
First Posted : February 24, 2020
Last Update Posted : January 9, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Diffuse Large B Cell Lymphoma Advanced Solid Tumor Non-small Cell Lung Cancer Small Cell Lung Cancer Metastatic Melanoma | Drug: BGB-10188 Drug: Zanubrutinib Drug: Tislelizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2, Dose Escalation and Expansion Study of BGB-10188, a Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor, Combined With Zanubrutinib in Patients With Mature B-Cell Malignancies and Combined With Tislelizumab in Patients With Solid Tumors |
Actual Study Start Date : | May 25, 2020 |
Estimated Primary Completion Date : | March 26, 2025 |
Estimated Study Completion Date : | November 7, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A: BGB-10188 Monotherapy Dose Escalation
BGB-10188 capsules administered orally once daily (QD) in 5 cohorts of escalating doses
|
Drug: BGB-10188
Administered as specified in the treatment arm |
Experimental: Part B: BGB-10188 + Zanubrutinib Dose Escalation
BGB-10188 capsules administered orally QD at the latest cleared dose of BGB-10188 monotherapy (Part A) in combination with zanubrutinib 160mg (2*80mg capsules) administered orally twice daily (BID)
|
Drug: BGB-10188
Administered as specified in the treatment arm Drug: Zanubrutinib Administered as specified in the treatment arm
Other Names:
|
Experimental: Part C: BGB-10188 + Zanubrutinib Dose Expansion
BGB-10188 capsules administered orally QD at RP2D of part B in combination with zanubrutinib 160mg (2*80mg capsules) administered orally BID
|
Drug: BGB-10188
Administered as specified in the treatment arm Drug: Zanubrutinib Administered as specified in the treatment arm
Other Names:
|
Experimental: Part D: BGB-10188 + Tislelizumab Infusion Dose Escalation
BGB-10188 capsules administered orally QD in up to 6 cohorts of escalating doses in combination with tislelizumab 200mg IV infusion administered every 3 weeks (Q3W)
|
Drug: BGB-10188
Administered as specified in the treatment arm Drug: Tislelizumab Administered as specified in the treatment arm
Other Name: BGB-A317 |
Experimental: Part E: BGB-10188 + Tislelizumab Infusion Dose Expansion
BGB-10188 capsules administered orally QD at RP2D of part D in combination with tislelizumab 200mg IV infusion administered Q3W
|
Drug: BGB-10188
Administered as specified in the treatment arm Drug: Tislelizumab Administered as specified in the treatment arm
Other Name: BGB-A317 |
- Part A: The recommended Phase 2 dose (RP2D) of BGB-10188 monotherapy [ Time Frame: Up to 8 Weeks ]
- Part B: RP2D of BGB-10188 in combination with zanubrutinib [ Time Frame: Up to 8 Weeks ]
- Part D: RP2D of BGB-10188 in combination with tislelizumab [ Time Frame: Up to 8 Weeks ]
- Part C and E: Overall response rate (ORR) [ Time Frame: Up to approximately 5 years and 6 months ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Parts A, B, and D: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 5 years and 6 months ]
- Parts A, B, and D: Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to approximately 5 years and 6 months ]
- Parts A, B and D: Number of participants experiencing Adverse Events (AEs) Leading to Discontinuation [ Time Frame: Up to approximately 5 years and 6 months ]
- Parts A, B, and D: Overall response rate (ORR) [ Time Frame: Up to approximately 5 years and 6 months ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Parts B, C, D, and E: Duration of response (DOR) [ Time Frame: Up to approximately 5 years and 6 months ]DOR is defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death, whichever occurs first
- Parts B, C, D, and E: Time to response (TTR) [ Time Frame: Up to approximately 5 years and 6 months ]TTR is defined as the time from treatment initiation to the first documentation of response
- Parts C and E: Progression-free survival (PFS) [ Time Frame: Up to approximately 5 years and 6 months ]PFS is defined as the time from treatment initiation to the first documentation of progression or death due to any cause, whichever happens first
- Parts D and E: Disease control rate (DCR) [ Time Frame: Up to approximately 5 years and 6 months ]
- Parts A, B, C, D, and E: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Parts A, B, C, D, and E: Area under the plasma concentration-time curve (AUC) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Parts C and E: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 5 years and 6 months ]
- Parts C and E: Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to approximately 5 years and 6 months ]
- Parts C and E: Number of participants experiencing Adverse Events (AEs) Leading to Treatment Discontinuation [ Time Frame: Up to approximately 5 years and 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Parts A, B and C
-
Confirmed diagnosis of one of the following:
- Part A: R/R CLL/SLL, R/R MZL, R/R FL, R/R MCL or R/R DLBCL
- Part B: R/R FL, R/R MCL, or R/R DLBCL
- Part C: R/R FL, R/R MCL, or R/R DLBCL
-
Participants with MZL, FL, MCL, DLBCL, or SLL must have at least one bi-dimensionally measurable nodal lesion >1.5 cm in the longest diameter or extranodal lesion that is > 1cm in the longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Lugano Classification.
Parts D and E
- Part D: Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy (including prior chemotherapy, radiotherapy, target therapy and immunotherapy as locally, or guidance approved therapy) or for which treatment is not available or not tolerated. Enrollment will be limited to participants 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 participant 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.
- Part E: Participants with NSCLC or metastatic melanoma that has progressed from PD 1/PD-L1 antibody treatment or participants with SCLC with no prior PD 1/PD-L1 antibody treatment.
- Participants must have ≥1 measurable lesion as defined by RECIST v1.1.
Key Exclusion Criteria:
Parts A, B and C
- History of allogeneic stem-cell transplantation or CAR-T cell therapy
-
For participants with DLBCL in Part A, classified as T-cell/histiocyte-rich large B-cell lymphoma, high-grade B-cell lymphoma with myelocytomatosis viral oncogene homolog (MYC) and B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, Epstein-barr virus positive DLBCL, and transformed DLBCL.
Parts A, B, C, D and E
- Prior exposure to PI3K inhibitor. For participants in Part B and Part C, prior exposure to BTK inhibitor and/or PI3K inhibitor.
- 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.
- 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.
-
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. Participants with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282018
Contact: BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |
Australia | |
Hematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital | Recruiting |
Adelaide, Australia, 5000 | |
Blacktown Hospital | Recruiting |
Blacktown, Australia, 2148 | |
Monash Hospital - Hematology | Recruiting |
Clayton, Australia | |
St. Vincent Hospital - Sydney - Hematology/Oncology | Recruiting |
Darlinghurst, Australia | |
Austin Hospital - Hematology | Recruiting |
Heidelberg, Australia | |
Perth Blood Institute | Recruiting |
West Perth, Australia | |
China, Fujian | |
Fujian Cancer Hospital | Recruiting |
Fuzhou, Fujian, China, 350014 | |
China, Hangzhou | |
Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting |
Zhejiang, Hangzhou, China, 310009 | |
China, Hunan | |
Third Xiangya Hospital of Central South University | Recruiting |
Changsha, Hunan, China | |
China, Jiangsu | |
First Affiliated Hospital of Soochow University | Recruiting |
Suzhou, Jiangsu, China | |
China, Shandong | |
Jining No. 1 People's Hospital | Recruiting |
Jining, Shandong, China, 272073 | |
China, Shanghai | |
Fudan University Zhongshan Hospital | Recruiting |
Shanghai, Shanghai, China, 200032 | |
China, Sichuan | |
West China Hospital | Recruiting |
Chengdu, Sichuan, China, 610041 |
Study Director: | Study Director | BeiGene |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT04282018 |
Other Study ID Numbers: |
BGB-A317-3111-10188-101 |
First Posted: | February 24, 2020 Key Record Dates |
Last Update Posted: | January 9, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Lung Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Small Cell Lung Carcinoma Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia Lymphoma, B-Cell Leukemia, B-Cell Zanubrutinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |