Recruiting
Phase 1

BG-C137

Sponsor:

BeOne Medicines

Code:

NCT06625593

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BG-C137

Anticancer Agents

Study Details

Brief summary:

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).

Conditions

Advanced Solid Tumor

Study ID

NCT06625593

Start date

Dec 9, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

168 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Monotherapy Dose Escalation and Safety Expansion

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

experimental: Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion

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

experimental: Phase 1b: Dose Expansion

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

Interventions

BG-C137

Administered intravenously

Anticancer Agents

Administered intravenously or orally

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137 [ Time Frame: Up to approximately 2 years ]
  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agents [ Time Frame: Up to approximately 2 years ]
  • Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137 [ Time Frame: Up to approximately 2 years ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Locations

Usc Norris Comprehensive Cancer Center (Nccc)

Recruiting

Los Angeles, California, United States, 90089-1019

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-3907

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-4433

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792-0001

More Information

Sponsor

BeOne Medicines

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • BG-C137
  • Advanced Solid Tumor
  • First-in-human
  • FGFR2b
  • ADC
  • Fibroblast growth factor receptor 2b

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-07-09.