BG-C0979 (alone or with tislelizumab) for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human Phase 1 trial uses a dose-escalation (Phase 1a) and dose-expansion (Phase 1b) design to define safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BG-C0979 given alone or with the PD-1 antibody tislelizumab. Phase 1a will identify tolerable dose levels and safety signals, while Phase 1b includes monotherapy optimization/expansion cohorts and a combination expansion cohort for patients without prior systemic therapy for advanced disease. Eligible participants are adults with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who meet the study's prior-treatment and health criteria. Study procedures include serial safety assessments, blood sampling for PK, and tumor imaging to track responses across participating U.S. and Australian centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• John Theurer Cancer Center Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• Next Oncology San Antonio
  San Antonio, Texas, United States Recruiting
• Northern Beaches Hospital
  Frenchs Forest, New South Wales, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 8778285568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.