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

Send

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	18years - 100years
Treatment	tislelizumab, Zanubrutinib, BGB-10188
Clinical Study Identifier	NCT04282018
Sponsor	BeiGene
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

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.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

squamous cell carcinoma

endometrial carcinoma

chronic lymphocytic leukemia

lymphoma

nasopharyngeal carcinoma

carcinoma

triple-negative breast cancer

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

non-small cell lung cancer

cervical cancer

small cell lung cancer

renal cell carcinoma

high-frequency microsatellite instability

zanubrutinib

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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