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NCT07414836PHASE1Recruiting

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

BeOne Medicines

Start Date

4/13/2026

Completion Date

4/30/2029

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload. * Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

BG-C0979

DRUG

Tislelizumab

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Conditions

Advanced Solid Tumor

Locations

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Next Oncology San Antonio

San Antonio, Texas 78229

United States

Northern Beaches Hospital

Frenchs Forest, New South Wales NSW 2086

Australia

Liverpool Hospital

Liverpool, New South Wales NSW 2170

Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland QLD 4101

Australia

Cabrini Hospital Malvern

Malvern, Victoria VIC 3144

Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, Chongqing Municipality 400037

China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian 350028

China

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, Guangdong 510245

China

Yichang Central Peoples Hospital

Yichang, Hubei 443003

China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality 201321

China

Hospital Universitario Vall Dhebron

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040

Spain

Next Oncology Madrid

Madrid, 28223

Spain