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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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:
1. Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases
2. Have measurable disease and/or evaluable disease outside CNS
3. 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
4. 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
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 — Approximately 24 Months 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.
Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902 — Approximately 24 Months RDFE of BG-C0902 will be determined based upon the MTD or MAD.
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy — Approximately 24 Months RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Phase 1b: Overall Response Rate (ORR) — Approximately 24 Months 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.
Trial sites (14)
Facility
City
Region
Status
The University of Texas Md Anderson Cancer Center
Houston
Texas
Recruiting
Next Oncology
San Antonio
Texas
Recruiting
Next Oncology Virginia
Fairfax
Virginia
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
Recruiting
Cancer Research South Australia
Adelaide
South Australia
Recruiting
Monash Health
Clayton
Victoria
Recruiting
The Alfred Hospital
Melbourne
Victoria
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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