BG-C0979 for Solid Tumors

Recruiting at 2 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeOne Medicines

Must not be taking: ADAM9-targeted ADCs, TOPO1 ADCs

Disqualifiers: Leptomeningeal disease, Brain metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

Inclusion Criteria

* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.

I am fully active or have only minor physical limitations.

My organs are working well enough for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive increasing doses of BG-C0979 as monotherapy to determine the maximum tolerated dose

Up to approximately 10 months

Phase 1a: Safety Expansion

Participants receive BG-C0979 at selected safe dose levels for further evaluation

Up to approximately 24 months

Phase 1b: Dose Optimization and Expansion

Participants receive BG-C0979 as monotherapy in dose optimization and expansion phases

Up to approximately 24 months

Phase 1b: Combination Therapy Expansion

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

Up to approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BG-C0979
• Tislelizumab

How Is the Trial Designed?

Group I: Phase 1b, Part B: Combination Therapy Expansion Experimental Treatment 2 Interventions

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

Group II: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion Experimental Treatment 1 Intervention

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.

Group III: Phase 1a: Monotherapy Safety Expansion Experimental Treatment 1 Intervention

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.

Group IV: Phase 1a: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

BeOne Medicines

Lead Sponsor