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

A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors

This trial will try the antibody-drug conjugate BG-C0979, alone or combined with tislelizumab, in adults with advanced solid tumors to see if it is safe, how it acts in the body, and whether it shows early signs of shrinking tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeOne Medicines (industry)
• Drugs / interventions: tislelizumab
• Locations: 4 sites (San Antonio, Texas and 3 other locations)
• Trial ID: NCT07414836 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who meet the trial's prior-treatment and health requirements (as specified for each Phase 1a/1b cohort) are the intended participants.

Not a fit: Patients with poor organ function, rapidly declining performance status, or who do not meet the study's eligibility or prior-treatment criteria are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, BG-C0979 could provide a new targeted treatment option that improves tumor control for some patients with advanced solid tumors.

How similar studies have performed: Other antibody-drug conjugates and combinations with PD-1 inhibitors have shown meaningful responses in several cancers, but targeting ADAM9 is a novel approach with limited prior human data.

Eligibility criteria

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.

Where this trial is running

San Antonio, Texas and 3 other locations

• Next Oncology San Antonio — San Antonio, Texas, United States (RECRUITING)
• Northern Beaches Hospital — Frenchs Forest, New South Wales, Australia (RECRUITING)
• Icon Cancer Centre South Brisbane — South Brisbane, Queensland, Australia (RECRUITING)
• Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Study Director

Conditions: Advanced Solid Tumor, ADAM9, antibody-drug conjugate