BG-T187 alone and with other cancer medicines for adults with advanced solid tumors

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

This trial will test whether BG-T187, given alone and together with other cancer drugs, is safe and shows early anti-tumor activity in adults with advanced solid tumors who have already had prior treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeOne Medicines (Industry-sponsored)
• Locations: 26 sites (Hackensack, New Jersey and 25 other locations)
• Trial ID: NCT06598800 on ClinicalTrials.gov

What this trial studies

This first-in-human, open-label Phase 1a/1b multicenter trial uses dose-escalation followed by dose-expansion cohorts to test BG-T187 alone and in combination with other therapeutic agents. The primary goals are to determine safety, tolerability, pharmacokinetics, and pharmacodynamics and to identify recommended dosing, with secondary endpoints including preliminary antitumor activity assessed by RECIST v1.1. Eligible participants are adults with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have received prior therapy, have ECOG performance status ≤1, measurable disease per protocol, and adequate organ function. Study visits include dosing, safety monitoring, PK/PD sampling, and tumor assessments at participating U.S. cancer centers.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic unresectable solid tumors who have received prior therapy, have ECOG 0–1, at least one measurable lesion per RECIST v1.1 (as required by the specific phase cohorts), and adequate organ function.

Not a fit: Patients with uncontrolled or untreated brain metastases or leptomeningeal disease, a history of severe hypersensitivity to monoclonal antibodies or BG-T187 components, recent other malignancies within protocol-specified windows, or inadequate organ function are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, BG-T187 could provide a new targeted treatment option or improve responses for some patients with EGFR- or c-MET–driven advanced solid tumors.

How similar studies have performed: Targeting EGFR and c-MET has produced benefits in certain cancers, but BG-T187 is being tested in humans for the first time so its safety and effectiveness are not yet established.

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.
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.

Where this trial is running

Hackensack, New Jersey and 25 other locations

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

Study contacts

• Study coordinator: Study Director

Conditions Advanced Solid Tumor; Advanced Solid Tumors; First-in-human; BG-T187; EGFR; c-MET