A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors.

Study Purpose

The objective of this study is to assess the overall response rate, evaluate the antitumor activity, and characterize the safety and tolerability of BGB-A445 alone or in combination with tislelizumab in participants With Advanced or Metastatic Urothelial Carcinoma (UC), Renal Cell Carcinoma (RCC), or Melanoma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants described in the following cohorts, who have received at least 1 but no more than 3 lines of prior systemic therapy for histologically or cytologically confirmed advanced and/or metastatic UC, RCC or melanoma Participants must not have received prior therapy targeting OX40 or any other T-cell agonists. 2. Has at least 1 measurable lesion as defined per RECIST v1.1. 3. Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample. 4. ECOG PS ≤ 1 (Participants with UC could have an ECOG PS ≤ 2) and a life expectancy of≥ 3 months. 5. Adequate organ function as indicated by the laboratory values up to the first dose of study drug(s)

Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled brain metastasis. 2. Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy. 3. Any active malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent. 4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions: 1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) 2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption. 3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen) 5. With uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia occurring ≤ 14 days before the first dose of study drug(s) Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05661955
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

BeiGene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma
Arms & Interventions

Arms

Experimental: Previously Treated UC Cohort A

BGB-A445 Monotherapy

Experimental: Previously Treated UC Cohort B

BGB-A445 and Tislelizumab

Experimental: Previously Treated RCC Cohort C

BGB-A445 Monotherapy

Experimental: Previously Treated RCC Cohort D

BGB-A445 and Tislelizumab

Experimental: Previously Treated Melanoma Cohort E

BGB-A445 Monotherapy

Experimental: Previously Treated Melanoma Cohort F

BGB-A445 and Tislelizumab

Interventions

Drug: - BGB-A445

administered intravenously

Drug: - Tislelizumab

administered intravenously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University First Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University First Hospital

Beijing, Beijing, 100034

Beijing Cancer Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, Beijing, 100142

Fujian Cancer Hospital, Fuzhou, Fujian, China

Status

Recruiting

Address

Fujian Cancer Hospital

Fuzhou, Fujian, 350014

Lanzhou University Second Hospital, Lanzhou, Gansu, China

Status

Recruiting

Address

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030

Guangzhou, Guangdong, China

Status

Recruiting

Address

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000

Sun Yat Sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060

Nanning, Guangxi, China

Status

Recruiting

Address

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021

Harbin, Heilongjiang, China

Status

Recruiting

Address

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450000

Zhengzhou, Henan, China

Status

Recruiting

Address

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052

Wuhan, Hubei, China

Status

Recruiting

Address

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030

Changsha, Hunan, China

Status

Recruiting

Address

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011

Nanjing, Jiangsu, China

Status

Recruiting

Address

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008

The First Hospital of Jilin University, Changchun, Jilin, China

Status

Recruiting

Address

The First Hospital of Jilin University

Changchun, Jilin, 130021

Liaoning Cancer Hospital and Institute, Shenyang, Liaoning, China

Status

Recruiting

Address

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042

Shandong Cancer Hospital, Jinan, Shandong, China

Status

Recruiting

Address

Shandong Cancer Hospital

Jinan, Shandong, 250117

Jining No Peoples Hospital Main Branch, Jining, Shandong, China

Status

Recruiting

Address

Jining No Peoples Hospital Main Branch

Jining, Shandong, 272002

Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China

Status

Recruiting

Address

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041

Tianjin, Tianjin, China

Status

Recruiting

Address

The Second Affiliated Hospital of Tianjin Medical University

Tianjin, Tianjin, 300000

Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin, 300060

Wenzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000

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