Chronic Lymphocytic LeukemiaPhase 1/2NCT04282018
Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
A Phase 1/2 study testing BGB-10188, Zanubrutinib and Tislelizumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeiGene at 24 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma
- What is being tested?
- BGB-10188, Zanubrutinib and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 29 Apr 2020to 28 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Parts A, B and C
- History of allogeneic stem-cell transplantation or chimeric antigen receptor-T (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 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.
Show all 12Show fewer
- 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.
- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
China16 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
Jining No Peoples Hospital West Branch
Jining, Shandong, 272000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hubei Cancer Hospital
Wuhan, Hubei, 430079
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Pindara Private Hospital
Benowa, Queensland, 4217
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148
Monash Health
Clayton, Victoria, 3168
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120
Austin Health
Heidelberg, Victoria, 3084
Perth Blood Institute
West Perth, Western Australia, 6005
About this study
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
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.
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- BGB-10188, Zanubrutinib, Tislelizumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-10188Drug
Administered as specified in the treatment arm
ZanubrutinibDrug
Also called BGB-3111, Brukinsa
Administered as specified in the treatment arm
TislelizumabDrug
Also called BGB-A317, Tevimbra, Tizveni
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation- BGB-10188- 60 mg | Experimental | Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) received BGB-10188 60 milligrams (mg) orally, once daily (QD) from Cycle 1 day 1 (C1D1) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. Receives: Drug: BGB-10188 |
| Part A: Dose Escalation- BGB-10188- 120 mg | Experimental | Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. Receives: Drug: BGB-10188 |
| Part A: Dose Escalation- BGB-10188- 240 mg | Experimental | Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 240 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. Receives: Drug: BGB-10188 |
| Part A: Dose Escalation- BGB-10188- 360 mg | Experimental | Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 360 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. Receives: Drug: BGB-10188 |
| Part A: Dose Escalation- BGB-10188- 540 mg | Experimental | Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 540 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. Receives: Drug: BGB-10188 |
| Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg | Experimental | Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, twice a day (BID) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. Receives: Drug: BGB-10188; Drug: Zanubrutinib |
| Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg | Experimental | Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg orally, QD from C1D1, followed by tislelizumab 200 mg intravenously (IV) on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg | Experimental | Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg | Experimental | Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 80 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg | Experimental | Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg | Experimental | Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg | Experimental | Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 540 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg | Experimental | Participants with platinum-resistant ovarian cancer (PROC) were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
| Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg | Experimental | Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days. Receives: Drug: BGB-10188; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: The Recommended Dose for Expansion (RDFE) of BGB-10188 Monotherapy in Hematologic Malignancies
The RDFE of BGB-10188 monotherapy in participants with hematologic malignancies was planned to be determined from safety, tolerability, pharmacokinetic (PK), and any other relevant and available data based on recommendations from the Safety Monitoring Committee. Part A dose-escalation enrolled participants with R/R CLL/SLL, MZL, FL, MCL, and DLBCL up to 540 mg, however the maximum tolerated dose was not reached and the RDFE could not be determined based on the data that were collected.
Measured: Up to 28 days
Part B: The RDFE of BGB-10188 in Combination With Zanubrutinib in Hematologic Malignancies
The RDFE of BGB-10188 in combination with zanubrutinib was planned to be determined from safety, tolerability, PK, and any other relevant and available data obtained, based on recommendation of the Safety Monitoring Committee.
The RDFE could not be determined since not all planned dose cohorts in this part of the study were enrolled and not enough data were collected to establish the RDFE.
Measured: Up to 28 days
Part D: The RDFE of BGB-10188 in Combination With Tislelizumab in Advanced Solid Tumors
The RDFE of BGB-10188 in combination with tislelizumab was determined based on the totality of safety, tolerability, PK, and any other relevant and available data that were obtained from the dose escalation phase for Part E.
Measured: Up to 28 days
Part E: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 10.0 months
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Measured: Part A: 47.2 Months; Part B: 24 Months; Part D: 15.2 Months; Part E: 10 Months
Secondary outcomes (23)
Parts A and B: ORR as Assessed by Investigator
ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Part A: up to 47.2 months and Part B: up to 24 months
Part A: Observed Maximum Plasma Concentration (Cmax) of BGB-10188 After a Single Dose
Cmax of BGB-10188 after a single dose was determined.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 168 hours post-dose on Day -7 (each cycle = 28 days)
Part A: Cmax of BGB-10188 at Steady State
Cmax of BGB-10188 at steady state was determined.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 15 (each cycle = 28 days)
Part A: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) After Single Dose
Area under the plasma concentration-time curve of BGB-10188 from time 0 to 24 hours (AUC0-24) was determined.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8,12, and 24 hours post-dose on Day-7 (each cycle = 28 days)
Part B: Duration of Response (DOR)
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression (PD) or death, whichever came first. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: Up to 24 months
Part B: Time to Response (TTR)
TRR was defined as the time from treatment initiation to the first documentation of response. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 24 months
Part B: Cmax of BGB-10188 After a Single Dose
Cmax of BGB-10188 after a single dose when given in combination with zanubrutinib was determined.
Measured: Pre-dose, 0.5,1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part B: Cmax of BGB-10188 at Steady State
Cmax of BGB-10188 at steady state when given in combination with zanubrutinib was determined.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 15 (each cycle = 28 days)
Part B: AUC 0-24 h of BGB-10188 After a Single Dose
AUC 0-24 h of BGB-10188 after a single dose when given in combination with zanubrutinib was determined.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part D: Overall Response Rate (ORR)
ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 15.2 months
Parts D and E: Duration of Response (DOR)
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of PD or death, whichever came first. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.
Measured: Part D: up to 15.2 months and Part E: up to 10.0 months
Parts D and E: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Part D: up to 15.2 months and Part E: up to 10.0 months
Parts D and E: Time to Response (TTR)
TTR was defined as the time from treatment initiation to the first documentation of response. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Part D: up to 15.2 months and Part E: up to 10.0 months
Part D: Cmax of BGB-10188 After a Single Dose
Cmax of BGB-10188 after a single dose when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part D: Cmax of BGB-10188 at Steady State
Cmax of BGB-10188 at steady state when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)
Part D: AUC 0-24h of BGB-10188 After Single Dose
AUC 0-24 h of BGB-10188 after a single dose when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part D: AUC 0-24h of BGB-10188 at Steady State
AUC 0-24 h of BGB-10188 at steady state when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)
Part E: Progression-Free Survival (PFS)
PFS was defined as the time from the date of the first dose of study drugs to the date of the first documentation of PD assessed by the investigator using RECIST v1.1 or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: Up to 10.0 months
Part E: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with best overall response, as defined by RECIST v1.1, of a CR, PR, or at least 24 weeks of SD. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Up to 10.0 months
Part E: Cancer Antigen (CA)-125 Response Rate Per Gynecological Cancer Intergroup
CA-125 response rate was defined as the percentage of participants achieving a CA-125 response according to the Gynecological Cancer Center Intergroup criteria, in which a response had occurred if there was at least a 50% reduction in CA-125 levels from baseline.
Measured: Up to 10.0 months
Part E: Cmax of BGB-10188 After Single Dose
Cmax of BGB-10188 after a single dose when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 1 (each cycle = 21 days)
Part E: Cmax of BGB-10188 at Steady State
Cmax of BGB-10188 at steady state when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)
Part E: AUC0-24h of BGB-10188 After Single Dose
AUC0-24 h of BGB-10188 after a single dose when given in combination with tislelizumab was determined.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose of Cycle 1 Day 1 (each cycle = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start29 Apr 2020
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282018
- Sponsor's protocol ID
- BGB-A317-3111-10188-101
- Other IDs
- CTR20220463
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2020
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04282018
- Acronym / sponsor ID
- BGB-A317-3111-10188-101
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation- BGB-10188- 60 mg | Experimental | Drug: BGB-10188Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) received BGB-10188 60 milligrams (mg) orally, once daily (QD) from Cycle 1 day 1 (C1D1) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. |
| Part A: Dose Escalation- BGB-10188- 120 mg | Experimental | Drug: BGB-10188Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. |
| Part A: Dose Escalation- BGB-10188- 240 mg | Experimental | Drug: BGB-10188Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 240 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. |
| Part A: Dose Escalation- BGB-10188- 360 mg | Experimental | Drug: BGB-10188Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 360 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. |
| Part A: Dose Escalation- BGB-10188- 540 mg | Experimental | Drug: BGB-10188Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 540 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. |
| Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg | Experimental | Drug: BGB-10188, Drug: ZanubrutinibParticipants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, twice a day (BID) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days. |
| Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg orally, QD from C1D1, followed by tislelizumab 200 mg intravenously (IV) on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. |
| Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. |
| Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with unresectable locally advanced or metastatic solid tumors received BGB-10188 80 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. |
| Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with unresectable locally advanced or metastatic solid tumors received BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days. |
| Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with unresectable locally advanced or metastatic solid tumors received BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days. |
| Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with unresectable locally advanced or metastatic solid tumors received BGB-10188 540 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days. |
| Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with platinum-resistant ovarian cancer (PROC) were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days. |
| Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg | Experimental | Drug: BGB-10188, Drug: TislelizumabParticipants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Parts A, B and C
- Confirmed diagnosis of one of the following:
- 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
Key exclusion criteria (12 listed)
- Parts A, B and C
- History of allogeneic stem-cell transplantation or chimeric antigen receptor-T (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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-10188Administered as specified in the treatment arm | Drug | Part A: Dose Escalation- BGB-10188- 120 mg, Part A: Dose Escalation- BGB-10188- 240 mg, Part A: Dose Escalation- BGB-10188- 360 mg, Part A: Dose Escalation- BGB-10188- 540 mg, Part A: Dose Escalation- BGB-10188- 60 mg, Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg, Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg, Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg, Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg |
| ZanubrutinibAlso: BGB-3111, BrukinsaAdministered as specified in the treatment arm | Drug | Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg |
| TislelizumabAlso: BGB-A317, Tevimbra, TizveniAdministered as specified in the treatment arm | Drug | Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg, Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg, Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg, Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg |
Primary outcome
Part A: The Recommended Dose for Expansion (RDFE) of BGB-10188 Monotherapy in Hematologic Malignancies
Time frame: Up to 28 days
The RDFE of BGB-10188 monotherapy in participants with hematologic malignancies was planned to be determined from safety, tolerability, pharmacokinetic (PK), and any other relevant and available data based on recommendations from the Safety Monitoring Committee. Part A dose-escalation enrolled participants with R/R CLL/SLL, MZL, FL, MCL, and DLBCL up to 540 mg, however the maximum tolerated dose was not reached and the RDFE could not be determined based on the data that were collected.
Part B: The RDFE of BGB-10188 in Combination With Zanubrutinib in Hematologic Malignancies
Time frame: Up to 28 days
The RDFE of BGB-10188 in combination with zanubrutinib was planned to be determined from safety, tolerability, PK, and any other relevant and available data obtained, based on recommendation of the Safety Monitoring Committee. The RDFE could not be determined since not all planned dose cohorts in this part of the study were enrolled and not enough data were collected to establish the RDFE.
Part D: The RDFE of BGB-10188 in Combination With Tislelizumab in Advanced Solid Tumors
Time frame: Up to 28 days
The RDFE of BGB-10188 in combination with tislelizumab was determined based on the totality of safety, tolerability, PK, and any other relevant and available data that were obtained from the dose escalation phase for Part E.
Part E: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Time frame: Up to 10.0 months
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Time frame: Part A: 47.2 Months; Part B: 24 Months; Part D: 15.2 Months; Part E: 10 Months
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
23 secondary outcomes
Parts A and B: ORR as Assessed by Investigator
Time frame: Part A: up to 47.2 months and Part B: up to 24 months
Part A: Observed Maximum Plasma Concentration (Cmax) of BGB-10188 After a Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 168 hours post-dose on Day -7 (each cycle = 28 days)
Part A: Cmax of BGB-10188 at Steady State
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 15 (each cycle = 28 days)
Part A: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) After Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8,12, and 24 hours post-dose on Day-7 (each cycle = 28 days)
Part B: Duration of Response (DOR)
Time frame: Up to 24 months
Part B: Time to Response (TTR)
Time frame: Up to 24 months
Part B: Cmax of BGB-10188 After a Single Dose
Time frame: Pre-dose, 0.5,1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part B: Cmax of BGB-10188 at Steady State
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 15 (each cycle = 28 days)
Part B: AUC 0-24 h of BGB-10188 After a Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part D: Overall Response Rate (ORR)
Time frame: Up to 15.2 months
Parts D and E: Duration of Response (DOR)
Time frame: Part D: up to 15.2 months and Part E: up to 10.0 months
Parts D and E: Disease Control Rate (DCR)
Time frame: Part D: up to 15.2 months and Part E: up to 10.0 months
Parts D and E: Time to Response (TTR)
Time frame: Part D: up to 15.2 months and Part E: up to 10.0 months
Part D: Cmax of BGB-10188 After a Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part D: Cmax of BGB-10188 at Steady State
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)
Part D: AUC 0-24h of BGB-10188 After Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)
Part D: AUC 0-24h of BGB-10188 at Steady State
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)
Part E: Progression-Free Survival (PFS)
Time frame: Up to 10.0 months
Part E: Clinical Benefit Rate (CBR)
Time frame: Up to 10.0 months
Part E: Cancer Antigen (CA)-125 Response Rate Per Gynecological Cancer Intergroup
Time frame: Up to 10.0 months
Part E: Cmax of BGB-10188 After Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 1 (each cycle = 21 days)
Part E: Cmax of BGB-10188 at Steady State
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)
Part E: AUC0-24h of BGB-10188 After Single Dose
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose of Cycle 1 Day 1 (each cycle = 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Related trials for Chronic Lymphocytic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BGB-10188, Zanubrutinib and Tislelizumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeiGene at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: The Recommended Dose for Expansion (RDFE) of BGB-10188 Monotherapy in Hematologic Malignancies (time frame: Up to 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.