RecruitingPhase 1

A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

United States, Australia63 participantsStarted 2025-11-10

Plain-language summary

This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases
✕. Have measurable disease and/or evaluable disease outside CNS
✕. 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
✕. No stereotactic radiation or whole-brain radiation ≤ 14 days before the first dose of study drug

What they're measuring

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Approximately 24 Months

Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Approximately 21 Days

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902

Timeframe: Approximately 24 Months

Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902

Timeframe: Approximately 24 Months

Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy

Timeframe: Approximately 24 Months

Phase 1b: Overall Response Rate (ORR)

Timeframe: Approximately 24 Months

Trial details

NCT IDNCT07181681

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-01

Contact for this trial

Study Director

1.877.828.5568 clinicaltrials@beonemed.com

View on ClinicalTrials.gov More Solid Tumors trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases
✕. Have measurable disease and/or evaluable disease outside CNS
✕. 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
✕. No stereotactic radiation or whole-brain radiation ≤ 14 days before the first dose of study drug

What they're measuring

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Approximately 24 Months

Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Approximately 21 Days

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902

Timeframe: Approximately 24 Months

Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902

Timeframe: Approximately 24 Months

Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy

Timeframe: Approximately 24 Months

Phase 1b: Overall Response Rate (ORR)

Timeframe: Approximately 24 Months