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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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).

Key facts

Study ID

NCT07414836

Run by

BeOne Medicines

People needed

84

Starts

2026-04-13

Expected to finish

2029-04-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Next Oncology San Antonio — San Antonio, Texas, United States (enrolling)
• Northern Beaches Hospital — Frenchs Forest, New South Wales, Australia (enrolling)
• Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
• Icon Cancer Centre South Brisbane — South Brisbane, Queensland, Australia (enrolling)
• Cabrini Hospital Malvern — Malvern, Victoria, Australia (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Chongqing, Chongqing Municipality, China (enrolling)
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China (enrolling)
• Yichang Central Peoples Hospital — Yichang, Hubei, China (enrolling)
• Fudan University Shanghai Cancer Centerpudong — Shanghai, Shanghai Municipality, China (enrolling)
• Hospital Universitario Vall Dhebron — Barcelona, Spain (enrolling)
• Hospital Clinic de Barcelona — Barcelona, Spain (enrolling)
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
• Next Oncology Madrid — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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