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

NCT07181681 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BG-C0902-101
• Study Type: interventional
• Target: 63
• Locations: 3 countries
• Sites: 12

Brief 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).

Conditions

Advanced Solid Tumor; Solid Tumors

Outcome Measures

Primary Outcomes (6)

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

  Approximately 24 Months

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

  Approximately 21 Days

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

  MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

  Approximately 24 Months

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

  RDFE of BG-C0902 will be determined based upon the MTD or MAD.

  Approximately 24 Months

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

  RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.

  Approximately 24 Months

• Phase 1b: Overall Response Rate (ORR)

  ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Approximately 24 Months

Secondary Outcomes (11)

• Phase 1a: ORR

  Approximately 24 Months

• Phase 1a and 1b: Duration of Response (DOR)

  Approximately 24 Months

• Phase 1a and 1b: Disease Control Rate (DCR)

  Approximately 24 Months

• Phase 1b: Progression-free Survival (PFS)

  Approximately 24 Months

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

  Approximately 24 Months

Study Arms (2)

Phase 1a: Dose Escalation and Safety Expansion of BG-C0902

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy.

Drug: BG-C0902

Phase 1b: Dose Expansion of BG-C0902

EXPERIMENTAL

The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors.

Drug: BG-C0902

Interventions

BG-C0902 DRUG

Administered by intravenous infusion

Phase 1a: Dose Escalation and Safety Expansion of BG-C0902; Phase 1b: Dose Expansion of BG-C0902

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated.
• Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening.
• Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug.
• Adequate bone marrow and organ function as indicated by the following laboratory values ≤ 14 days before the first dose of study drug
• Female participants of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 7 months after the last dose of study drug. They must also have a negative serum pregnancy test result ≤ 3 days before the first dose of study drug.
• Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of study drug.

You may not qualify if:

• History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins.
• For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:
• 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
• History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
• Participants with active or chronic corneal disorder, including but not limited to Sjögren's, Fuch's corneal dystrophy, 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.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (12)

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Next Oncology

San Antonio, Texas, 78229-6028, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Monash Health

Clayton, Victoria, VIC 3168, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, VIC 3004, Australia

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch

Shanghai, Shanghai Municipality, 201801, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (3); AU (3); CN (6)