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Study of BG-C0979 for Advanced Solid Tumors

This study is testing a new drug called BG-C0979, either alone or with another drug called tislelizumab, for adults with advanced solid tumors. These are cancers that have spread or cannot be removed by surgery, and for which standard treatments haven't worked or aren't suitable. The main goals are to see how safe BG-C0979 is, how well your body handles it, and if it shows any early signs of shrinking tumors. Researchers will also look for the highest safe dose of BG-C0979. This is a "first-in-human" study, meaning it's one of the first times this drug is being given to people. The study plans to enroll 84 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves two phases: Phase 1a to find the right dose and check safety, and Phase 1b to further evaluate the drug.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07414836

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~84 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:BG-C0979Tislelizumab

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Measured over Up to approximately 24 months
+4 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT07414836

Where you'd take part

This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cabrini Hospital Malvern

    Malvern, Victoria, Australiano site contact published

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality, Chinano site contact published

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Spainno site contact published

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spainno site contact published

    Recruiting

  • Hospital Universitario Vall Dhebron

    Barcelona, Spainno site contact published

    Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, Australiano site contact published

    Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jerseyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
8778285568
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Phase 1a: Number of Participants Experiencing Adverse Events (AEs)Up to approximately 24 months

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results.

  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 MonotherapyUp to approximately 10 months

    MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.

  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])Up to approximately 10 months

    The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available.

  • Phase 1b: Recommended Phase 2 Dose (RP2D)Up to approximately 24 months

    RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available.

  • Phase 1b: Overall Response Rate (ORR)Up to approximately 24 months

    ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).