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NCT06598800PHASE1Recruiting

Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

BeOne Medicines

Start Date

10/18/2024

Completion Date

9/30/2028

Summary

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced 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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC). 5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b. 6. Adequate organ function. Exclusion Criteria: 1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies. 2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis. 3. 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). 4. History of interstitial lung disease (ILD) or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening. 5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention). 6. Active hepatitis C. 7. 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). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Drug: BG-T187

DRUG

Other Therapeutic Agents

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Conditions

Advanced Solid Tumor

Locations

Hackensack University Medical Center

Hackensack, New Jersey 07601-1915

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Next Virginia

Fairfax, Virginia 22031

United States

Washington University, St Louis, Division of Oncology

Madison, Wisconsin 53708-8056

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Macquarie University

North Ryde, New South Wales NSW 2109

Australia

Cabrini Hospital Malvern

Malvern, Victoria VIC 3144

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality 400030

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

The Sixth Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong 510655

China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi 530021

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

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

Wuhan, Hubei 430030

China

Hubei Cancer Hospital

Wuhan, Hubei 430079

China

Linyi Peoples Hospital

Linyi, Shandong 276000

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch

Hangzhou, Zhejiang 310024

China

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do 16247

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea