A Study of BG-C477 in Participants With Advanced Solid Tumors

BeiGene

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Chemotherapy; Drug: BG-C477

Study type: Interventional

Funder types: Industry

Identifiers

NCT06596473

BG-C477-101

CTR20244563 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Full description

This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• ≥ 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 and for ≥ 6 months after the last dose of chemotherapy, 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, and for ≥ 3 months after chemotherapy, whichever comes later.

Exclusion criteria

• 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)

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 4 patient groups

Phase 1a: BG-C477 Monotherapy Dose Escalation

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.

Treatment:

Drug: BG-C477

Phase 1a: BG-C477 Monotherapy Safety Expansion

Experimental group

Description:

Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.

Treatment:

Drug: BG-C477

Phase 1b Part A: BG-C477 Monotherapy Dose Optimization

Experimental group

Description:

Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.

Treatment:

Drug: BG-C477

Phase 1b Part B: Combination Therapy Expansion

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with chemotherapy.

Treatment:

Drug: BG-C477

Drug: Chemotherapy