Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
NCT ID: NCT04282018
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
97 participants
INTERVENTIONAL
2020-05-25
2024-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A: BGB-10188 Monotherapy Dose Escalation
BGB-10188 capsules administered orally once daily (QD) in 5 cohorts of escalating doses
BGB-10188
Administered as specified in the treatment arm
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)
BGB-10188
Administered as specified in the treatment arm
Zanubrutinib
Administered as specified in the treatment arm
Part C: BGB-10188 + Zanubrutinib Dose Expansion
This Part was originally planned but was cancelled by the sponsor and will not be initiated.
BGB-10188
Administered as specified in the treatment arm
Zanubrutinib
Administered as specified in the treatment arm
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)
BGB-10188
Administered as specified in the treatment arm
Tislelizumab
Administered as specified in the treatment arm
Part E: BGB-10188 + Tislelizumab Infusion Dose Expansion
BGB-10188 capsules administered orally QD at two doses in combination with tislelizumab 200mg IV infusion administered Q3W
BGB-10188
Administered as specified in the treatment arm
Tislelizumab
Administered as specified in the treatment arm
Interventions
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BGB-10188
Administered as specified in the treatment arm
Zanubrutinib
Administered as specified in the treatment arm
Tislelizumab
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 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
CLL = chronic lymphocytic leukemia; SLL = small lymphocytic lymphoma; MZL = marginal zone lymphoma
2. 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
3. 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, 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 (OC), 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.
4. Part E: Participants with histologically or cytologically confirmed epithelial OC (including fallopian or primary peritoneal cancer) previously treated with 1 to 3 lines of systemic anticancer treatment; must be platinum resistant and checkpoint inhibitor (CPI) naïve.
5. Participants must have measurable disease as assessed by RECIST v1.1.
Exclusion Criteria
1. History of allogeneic stem-cell transplantation or chimeric antigen receptor-T (CAR-T) cell therapy.
2. 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 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
3. Prior exposure to PI3K inhibitor. For participants in Part B and Part C, prior exposure to BTK inhibitor and/or PI3K inhibitor.
4. 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.
5. 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.
6. 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Jining No Peoples Hospital West Branch
Jining, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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CTR20220463
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-3111-10188-101
Identifier Type: -
Identifier Source: org_study_id