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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT06598800

Run by

BeOne Medicines

People needed

153

Starts

2024-10-18

Expected to finish

2028-09-30

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
• Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
• 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).
• ≥ 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.
• Adequate organ function.

You may not qualify if…

• Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
• Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
• 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).
• 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.
• Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
• Active hepatitis C.
• 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.

Where it is running

• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Next Virginia — Fairfax, Virginia, United States (enrolling)
• Washington University, St Louis, Division of Oncology — Madison, Wisconsin, United States (enrolling)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
• Macquarie University — North Ryde, New South Wales, Australia (enrolling)
• Cabrini Hospital Malvern — Malvern, Victoria, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Fujian Medical University Union Hospitalqishan Branch — Fuzhou, Fujian, China (enrolling)
• The Sixth Affiliated Hospital, Sun Yat Sen University — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Linyi Peoples Hospital — Linyi, Shandong, China (enrolling)
• Affiliated Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (enrolling)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicinezhijiang Branch — Hangzhou, Zhejiang, China (enrolling)
• The Catholic University of Korea, St Vincents Hospital — PaldalGu SuwonSi, Gyeonggi-do, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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