NCT04282018CompletedPhase 1/2
Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
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
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
The purpose of this study was to determine the maximum tolerated dose (MTD), recommended dose for expansion (RDFE), safety and tolerability of BGB-10188 as monotherapy in participants with relapsed/refractory (R/R) mature B-cell malignancies; in combination with zanubrutinib in participants with R/R follicular lymphoma (FL), R/R mantle cell lymphoma (MCL) or R/R diffuse large B-cell lymphoma (DLBCL); and in combination with tislelizumab in participants with advanced solid tumors.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 5 Feb 2020
- Start date
- 29 Apr 2020
- Primary completion date
- 28 Aug 2024
- Lead sponsor
- BeiGene
- Diseases
- Diffuse large B-cell lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukaemia
- NCT number
- NCT04282018
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 97
- From 29 Apr 2020 to the primary completion date, 28 Aug 2024
- 24 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 was later, before first dose.
Other illness
- History of allogeneic stem-cell transplantation or chimeric antigen receptor-T (CAR-T) cell therapy.
- 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 were eligible if HCV ribonucleic acid (RNA) was undetectable
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Other
- Parts A, B and C
- 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
Who the study is looking for
- 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
- CLL = chronic lymphocytic leukemia; SLL = small lymphocytic lymphoma; MZL = marginal zone lymphoma
- Participants with MZL, FL, MCL, DLBCL, or SLL must have had at least one bi-dimensionally measurable nodal lesion greater than (\>) 1.5 centimeters (cm) in the longest diameter or extranodal lesion that is \> 1 cm 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 was limited to participants with advanced solid tumors for which there was clinical evidence of response to T-cell based immuno-oncology agents (e.g., 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 required sponsor's approval.
- 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 have been platinum resistant and checkpoint inhibitor (CPI) naïve.
- Participants must have had measurable disease as assessed by RECIST v1.1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Pindara Private Hospital Coordinator of this site? Confirm its status | Benowa | Australia | Unknown status |
| Blacktown Cancer and Haematology Centre Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Saint Vincents Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Gallipoli Medical Research Foundation Coordinator of this site? Confirm its status | Greenslopes | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Perth Blood Institute Coordinator of this site? Confirm its status | West Perth | Australia | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Zhejiang University College of Medicine Second Affiliated Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Jining No Peoples Hospital West Branch Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Affiliated Zhongshan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.