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A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors

A Multicenter Open-Label Phase 1a/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors

NCT06487858•BeOne Medicines

View on ClinicalTrials.gov

Summary

This is a first-in-human (FIH) study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046 as a single agent and in combination with tislelizumab (BGB-A317) in participants with advanced or metastatic immune-sensitive solid tumors.

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
•Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom standard treatment is not available, not tolerated, or determined not appropriate based on the investigator's judgement
•≥ 1 measurable lesion per RECIST v1.1
•Able to provide an archived tumor tissue sample
•Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
•Adequate organ function
•Life expectancy \>12 weeks as determined by the investigator

Exclusion Criteria

•Active leptomeningeal disease or uncontrolled, untreated brain metastasis
•Active autoimmune diseases or history of autoimmune diseases that may relapse
•Any malignancy ≤ 3 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 (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
•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)
•History of interstitial lung disease, noninfectious pneumonitis (including immune mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
•Experienced ≥ Grade 3 imAE(s) on prior immuno-oncology agent (anti-PD-1, anti CTLA4, or other experimental drugs)
•Uncontrolled diabetes \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drug(s).
•Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s)
•Immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents

Locations (8)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

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

Wuhan, Hubei, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Jinan Central Hospital

Jinan, Shandong, China

Jining No1 Peoples Hospital West Branch

Jining, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

July 16, 2024

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 18, 2026

Enrollment

ESTIMATED participants

Conditions

Solid Tumor

Interventions

BGB-R046

DRUG

Tislelizumab

DRUG

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors

Inclusion Criteria

Exclusion Criteria

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