RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06598800

Registry updated: 2026-09-11

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Description

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.

Interventions

Drug: BG-T187 (Drug)
administered subcutaneously
Other Therapeutic Agents (Drug)
administered intravenously

Eligibility criteria

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.

Conditions

Advanced Solid Tumor

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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