A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors

BeOne Medicines

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BG-C0979; Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07414836

2025-524857-15-00 (EU Trial (CTIS) Number)

BG-C0979-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
• Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
• Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
• Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
• Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have adequate organ function.

Exclusion criteria

• Prior treatment with any ADAM9-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 inhibitor as payload.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

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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84 participants in 4 patient groups

Phase 1a: Monotherapy Dose Escalation

Experimental group

Description:

Participants will receive increasing doses of BG-C0979 as monotherapy.

Treatment:

Drug: BG-C0979

Phase 1a: Monotherapy Safety Expansion

Experimental group

Description:

Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion.

Treatment:

Drug: BG-C0979

Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion

Experimental group

Description:

Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a.

Treatment:

Drug: BG-C0979

Phase 1b, Part B: Combination Therapy Expansion

Experimental group

Description:

Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.

Treatment:

Drug: Tislelizumab

Drug: BG-C0979