Brief Title: Study of BGB-10188 as Monotherapy and in Combination With Zanubrutinib and Tislelizumab

  • STATUS
    Recruiting
  • End date
    Apr 26, 2025
  • participants needed
    150
  • sponsor
    BeiGene
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Updated on 19 February 2024
See if I qualify
cancer
breast cancer
ct scan
solid tumour
squamous cell carcinoma
lung cancer
solid tumor
ovarian cancer
cancer of the ovary
MRI
endometrial carcinoma
chronic lymphocytic leukemia
lymphoma
nasopharyngeal carcinoma
carcinoma
triple-negative breast cancer
solid tumors
esophageal cancer
systemic therapy
b-cell lymphoma
mantle cell lymphoma
follicular lymphoma
transitional cell carcinoma
hepatocellular carcinoma
liver cancer
diffuse large b-cell lymphoma
metastatic melanoma
large b-cell lymphoma
cancer, hepatocellular
microsatellite instability high
urothelial carcinoma
refractory follicular lymphoma
cancer, ovarian
msi-h
tislelizumab
melanoma
non-small cell lung cancer
cervical cancer
small cell lung cancer
renal cell carcinoma
high-frequency microsatellite instability
zanubrutinib

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD), recommended Phase 2 dose(RP2D),safety & tolerability of BGB-10188: as monotherapy in participants with mature B-cell malignancies; oin combination with zanubrutinib in participants with relapse/refractory follicular lymphoma (R/R FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL); and in combination with tislelizumab in participants with advanced solid tumors.

Details
Condition Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, follicular lymphoma, follicular lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma, MALT Lymphoma, Mantle cell lymphoma, Mantle cell lymphoma, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Metastatic Melanoma, Advanced Solid Tumor
Age 18-100 years
Treatment tislelizumab, Zanubrutinib, BGB-10188
Clinical Study IdentifierNCT04282018
SponsorBeiGene
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Part A, B and C
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
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
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

Exclusion Criteria

Part A, B and C
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
\. 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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cancer
breast cancer
ct scan
solid tumour
squamous cell carcinoma
lung cancer
solid tumor
ovarian cancer
cancer of the ovary
MRI
endometrial carcinoma
chronic lymphocytic leukemia
lymphoma
nasopharyngeal carcinoma
carcinoma
triple-negative breast cancer
solid tumors
esophageal cancer
systemic therapy
b-cell lymphoma
mantle cell lymphoma
follicular lymphoma
transitional cell carcinoma
hepatocellular carcinoma
liver cancer
diffuse large b-cell lymphoma
metastatic melanoma
large b-cell lymphoma
cancer, hepatocellular
microsatellite instability high
urothelial carcinoma
refractory follicular lymphoma
cancer, ovarian
msi-h
tislelizumab
melanoma
non-small cell lung cancer
cervical cancer
small cell lung cancer
renal cell carcinoma
high-frequency microsatellite instability
zanubrutinib

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