Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07414836

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG-C0979

Drug

Administered by intravenous infusion.

Tislelizumab

Drug

Administered by intravenous infusion.

Other names: BGB-A317

Primary outcomes

  1. Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

    Time frame: 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.

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy

    Time frame: Up 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.

  3. Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])

    Time frame: 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.

  4. Phase 1b: Recommended Phase 2 Dose (RP2D)

    Time frame: 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.

  5. Phase 1b: Overall Response Rate (ORR)

    Time frame: 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).

Secondary outcomes

  1. Phase 1a: ORR

    Time frame: Up to approximately 24 months

    ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and 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).

  2. Phase 1a and 1b: Duration of Response (DOR)

    Time frame: Up to approximately 24 months

    DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.

  3. Phase 1a and 1b: Disease Control Rate (DCR)

    Time frame: Up to approximately 24 months

    DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease.

  4. Phase 1a: Plasma Concentration of BG-C0979

    Time frame: Up to approximately 3 months

  5. Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979

    Time frame: Up to approximately 3 months

  6. Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979

    Time frame: Up to approximately 3 months

  7. Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979

    Time frame: Up to approximately 3 months

  8. Phase 1b: Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to approximately 24 months

    Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results.

  9. Phase 1b: Progression-Free Survival

    Time frame: Up to approximately 24 months

    PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.

  10. Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC

    Time frame: Up to approximately 24 months

    rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first.

  11. Prostate-Specific Antigen (PSA) Response for Participants with CRPC

    Time frame: Up to approximately 24 months

    PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.

  12. Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab

    Time frame: Up to approximately 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

8778285568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.