臨床研究等提出・公開システム

A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients with Selected Advanced Solid Tumors

BG-C477-101

Tanaka Koichi

BeOne Medicines Japan

Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan

MedInfoJP@beigene.com

Hamano Fumiaki

BeOne Medicines Japan

Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan

+81-800-919-0351

MedInfoJP@beigene.com

Recruiting

April. 28, 2026

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

single assignment

treatment purpose

- Participants must sign the informed consent form (ICF) and be capable of giving written informed consent
- Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
- Phase 1a (Dose Escalation); Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator
Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy
Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease
- >_ 1 measurable lesion as assessed by RECIST v1.1
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of <_ 1
- Adequate organ function
- Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for >_ 8 months after the last dose of BG-C477, for >_ 6 months after the last dose of chemotherapy, and for >_ 4 months after the last dose of tislelizumab,whichever comes later
- 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 >_ 5 months after the last dose of BG-C477, for >_ 3 months after chemotherapy, and for >_ 4 months after the last dose of tislelizumab, whichever comes later.

- Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
- History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any malignancy <_ 2 years before the 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 (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

Both

Advanced Solid Tumors

Drug: BG-C477
Administered intravenously.

- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)]
Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Special Interest (AESI) criteria.
- Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) [Time Frame: Approximately 1 year]
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[s]) of BG-C477 [Time Frame: Approximately 1 year]
RDFE of BG-C477 monotherapy will be determined based upon available data.
- Phase 1b: Objective Response Rate (ORR) [Time Frame: Approximately 2 years]
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477 [Time Frame: Approximately 2 years]
RP2D established from Phase 1a for BG-C477 for administration alone and in combination with chemotherapy.

No

United States/Australia/New Zealand/South Korea/China/United Kingdom/Thailan/Malaysia