A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

BeOne Medicines

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Anticancer Agents; Drug: BG-C137

Study type: Interventional

Funder types: Industry

Identifiers

NCT06625593

2025-523572-23-00 (EU Trial (CTIS) Number)

BG-C137-101

CTR20244835 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed advanced or metastatic solid tumors.
2. Life expectancy of ≥ 3 months.
3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and/or a platinum in the advanced or metastatic setting
4. Tumors with FGFR2b expression/ or FGFR2 gene amplification. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.
5. ≥ 1 measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Adequate organ function as determined per protocol.

Exclusion criteria

1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
2. Active or chronic corneal disorder, 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.
3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives [whichever is shorter] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).
5. Toxicities due to prior therapy that have not recovered.
6. Any malignancy ≤ 2 years before 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 curatively.
7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline.

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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168 participants in 3 patient groups

Phase 1a: Monotherapy Dose Escalation and Safety Expansion

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy

Treatment:

Drug: BG-C137

Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion

Experimental group

Description:

Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation

Treatment:

Drug: Anticancer Agents

Drug: BG-C137

Phase 1b: Dose Expansion

Experimental group

Description:

Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications

Treatment:

Drug: BG-C137