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RecruitingLast updated: 30 June 2026

BG-C137-101: Evaluating a drug called BG-C137 in people with advanced or metastatic solid cancers with a FGFR2b expression or gene amplificationA Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

BG-C137-101

Clinical summary

Summary

This study is open to all Gastric Cancer (GC) / Gastro-oesophageal junction cancer (GEJC) patients, as well as patients with other solid tumour types with FGFR2b ≥1% as determined by central testing. 

It is investigating how safe and tolerable an antibody-drug conjugate that targets FGFR2b, called BG-C137 is, as well as how it interacts in the body and its anti-tumour activity. This will be done in two phases.

Participants should have had prior systemic therapy for their advanced or metastatic disease, with specific prior therapy requirements applying to each phase of the study.

In Phase 1a (Dose Escalation and Safety Expansion), sequential cohorts of increasing dose levels of intravenous BG-C137 will be evaluated. Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgement.

In Phase 1b (Dose Expansion), the recommended dose(s) of BG-C137 as determined in Phase 1a will be evaluated in people with select cancer types. 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 are eligible.

Conditions

This trial is treating people with solid cancers that are confirmed advanced or metastatic

Eligibility

Inclusion

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06625593 *
  • 2025-523572-23-00 *
  • BG-C137-101; CTR20244835

Trial sponsor

BeiGene

Scientific Title

A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

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