A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

NCT 06625593

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.

Intervention / Treatment 

  • Drug: BG-C137

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. Safety Expansion and Dose Expansion: Participants who have received 1 or 2 prior lines of systemic therapy in the advanced or metastatic setting.
  4. 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.

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