Brief Title: Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
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ClinicalTrials.gov Identifier: NCT04282018 |
Recruitment Status :
Recruiting
First Posted : February 24, 2020
Last Update Posted : December 1, 2021
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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 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 : | April 26, 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
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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 a dose level less than RP2D and RP2D 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 |
Experimental: Part C: BGB-10188 + Zanubrutinib Dose Expansion
BGB-10188 capsules administered orally QD at RP2D of part B in combination with zanbrutinib 160mg (2*80mg capsules) administered orally BID
|
Drug: BGB-10188
Administered as specified in the treatment arm Drug: Tislelizumab Administered as specified in the treatment arm |
Experimental: Part D: BGB-10188 + Tislelizumab Infusion Dose Escalation
BGB-10188 capsules administered orally QD in upto 4 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: Zanubrutinib Administered as specified in the treatment arm |
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 |
- Part A: The maximum tolerated dose (MTD) of BGB-10188 monotherapy [ Time Frame: Up to 8 Weeks ]
- Part A: The recommended Phase 2 dose (RP2D) of BGB-10188 monotherapy in mature B-cell malignancies [ Time Frame: Up to 8 Weeks ]
- Part A: Number of participants with mature B-cell malignancies experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part A: Number of participants with mature B-cell malignancies experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part A: Number of participants with mature B-cell malignancies experiencing Adverse Events (AEs) Leading to Discontinuation of BGB-10188 [ Time Frame: Up to 30 days posttreatment ]
- Part B: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part B: The recommended Phase 2 dose (RP2D) of BGB-10188 in combination with zanubrutinib [ Time Frame: Up to 8 Weeks ]
- Part B: Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part B: Number of participants experiencing Adverse Events (AEs) Leading to Treatment Discontinuation [ Time Frame: Up to 30 days posttreatment ]
- Part C: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part C: Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part C: Number of participants experiencing Adverse Events (AEs) Leading to Treatment Discontinuation [ Time Frame: Up to 30 days posttreatment ]
- Part D: RP2D of BGB-10188 in combination with tislelizumab [ Time Frame: Up to 8 Weeks ]
- Part D: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part D: Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part D: Number of participants experiencing Adverse Events (AEs) Leading to Treatment Discontinuation [ Time Frame: Up to 30 days posttreatment ]
- Part E: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part E: Number of participants experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 30 days posttreatment ]
- Part E: Number of participants experiencing Adverse Events (AEs) Leading to Treatment Discontinuation [ Time Frame: Up to 30 days posttreatment ]
- Part A: Overall response rate (ORR) [ Time Frame: 8 weeks for first 24 weeks, every 12 weeks for the next 24 weeks, and then every 16 weeks ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Part A: Area under the plasma concentration-time curve (AUC) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part A: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part B: Overall response rate (ORR) [ Time Frame: 8 weeks for first 24 weeks, every 12 weeks for the next 24 weeks, and then every 16 weeks ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Part B: Area under the plasma concentration-time curve (AUC) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part B: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part C: Overall response rate (ORR) [ Time Frame: 8 weeks for first 24 weeks, every 12 weeks for the next 24 weeks, and then every 16 weeks ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Part C: Area under the plasma concentration-time curve (AUC) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part C: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part D: Overall response rate [ Time Frame: At Week 10 and every 9 weeks posttreatment ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Part D: The preliminary anti-tumor activity of BGB-10188 in combination with tislelizumab as measured by duration of response (DOR) [ Time Frame: At Week 10 and every 9 weeks posttreatment ]
- Part D: The preliminary anti-tumor activity of BGB-10188 in combination with tislelizumab as measured by disease control rate (DCR) [ Time Frame: At Week 10 and every 9 weeks posttreatment ]
- Part D: Area under the plasma concentration-time curve (AUC) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part D: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part E: Overall response rate (ORR) [ Time Frame: At Week 10 and every 9 weeks posttreatment ]ORR is defined as the proportion of participants achieving a partial response (PR) or better
- Part E: The preliminary anti-tumor activity of BGB-10188 in combination with tislelizumab as measured by duration of response (DOR) [ Time Frame: At Week 10 and every 9 weeks posttreatment ]
- Part E: The preliminary anti-tumor activity of BGB-10188 in combination with tislelizumab as measured by disease control rate (DCR) [ Time Frame: At Week 10 and every 9 weeks posttreatment ]
- Part E: Area under the plasma concentration-time curve (AUC) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]
- Part E: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188 [ Time Frame: Predose up to 7 days postdose ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Part A, B and C
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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
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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
- 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.
- 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.
- 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
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History of allogeneic stem-cell transplantation in Part A, Part B, and Part C
Part A, B, C, D and E
- Prior exposure to 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.
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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.

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 | |
a) 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 | |
Royal Brisbane and Women's Hospital | Recruiting |
Herston, Australia, 4029 | |
Perth Blood Institute | Recruiting |
West Perth, Australia |
Study Director: | Yuan Liu, MD | 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: | December 1, 2021 |
Last Verified: | November 2021 |
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 Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
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 |