Recruiting
Phase 1

BG-C0979 & Tislelizumab

Sponsor:

BeOne Medicines

Code:

NCT07414836

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BG-C0979

Tislelizumab

Study Details

Brief summary:

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).

Conditions

Advanced Solid Tumor

Study ID

NCT07414836

Start date

Apr 13, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Monotherapy Dose Escalation

Participants will receive increasing doses of BG-C0979 as monotherapy.

experimental: Phase 1a: Monotherapy Safety Expansion

Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion.

experimental: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion

Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a.

experimental: Phase 1b, Part B: Combination Therapy Expansion

Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.

Interventions

BG-C0979

Administered by intravenous infusion.

Tislelizumab

Administered by intravenous infusion.

Primary outcome measure

  • Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy [ Time Frame: Up to approximately 10 months ]
  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) [ Time Frame: Up to approximately 10 months ]
  • Phase 1b: Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to approximately 24 months ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Study Director

8778285568clinicaltrials@beonemed.com

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

John Theurer Cancer Center Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Next Oncology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • ADAM9 (disintegrin and metalloproteinase 9)
  • antibody-drug conjugate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-06.