BG-C0902 alone and with other therapies for people with advanced solid tumors

A Phase 1a/b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, an Antibody-Drug Conjugate Targeting Epidermal Growth Factor Receptor (EGFR) × Mesenchymal-Epithelial Transition (MET), Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

This study will test whether BG-C0902, given alone or with other cancer drugs, is safe and can shrink tumors in people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeOne Medicines (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 13 sites (Houston, Texas and 12 other locations)
• Trial ID: NCT07181681 on ClinicalTrials.gov

What this trial studies

This first-in-human Phase 1a/1b study tests BG-C0902, a fully human antibody that targets EGFR and MET and is linked to a topoisomerase 1 inhibitor via a cleavable linker, in patients with advanced solid tumors. Phase 1a includes dose escalation and safety expansion to identify a tolerable dose and characterize pharmacokinetics and pharmacodynamics, and Phase 1b comprises dose-expansion cohorts and combination arms. Primary assessments focus on safety, tolerability, PK/PD, and preliminary antitumor activity using RECIST v1.1. Participants must provide tumor tissue, have measurable disease, ECOG performance status ≤1, and be treated at participating US cancer centers.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to curative therapy, with at least one measurable lesion, ECOG ≤1, adequate organ function, and available tumor tissue for testing.

Not a fit: Patients with curable disease, poor performance status (ECOG >1), inadequate organ function, pregnancy, or who cannot provide tumor tissue are unlikely to be eligible or to benefit from this phase 1 trial.

Why it matters

Potential benefit: If successful, BG-C0902 could provide a new targeted therapy that delivers a potent chemotherapy payload directly to tumors expressing EGFR and MET, potentially shrinking tumors while reducing systemic side effects.

How similar studies have performed: Antibody–drug conjugates carrying topoisomerase 1 inhibitors have shown activity in other tumor types, but a dual EGFR/MET-targeting ADC like BG-C0902 is a novel approach with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated.
* Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening.
* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug.
* Adequate bone marrow and organ function as indicated by the following laboratory values ≤ 14 days before the first dose of study drug
* Female participants of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 7 months after the last dose of study drug. They must also have a negative serum pregnancy test result ≤ 3 days before the first dose of study drug.
* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of study drug.

Exclusion Criteria:

* History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins.
* For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload.
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:

  1. Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases
  2. Have measurable disease and/or evaluable disease outside CNS
  3. No ongoing requirement for corticosteroids as therapy for CNS disease; off corticosteroids ≥ 14 days before dosing with study drug; anticonvulsants at a stable dose are allowed
  4. No stereotactic radiation or whole-brain radiation ≤ 14 days before the first dose of study drug
* History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
* Participants with active or chronic corneal disorder, including but not limited to Sjögren's, Fuch's corneal dystrophy, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Houston, Texas and 12 other locations

• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Next Oncology — San Antonio, Texas, United States (Recruiting)
• Next Virginia — Fairfax, Virginia, United States (Recruiting)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (Recruiting)
• Cancer Research South Australia — Adelaide, South Australia, Australia (Recruiting)
• Monash Health — Clayton, Victoria, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Study Director

Conditions Solid Tumors; Advanced Solid Tumor