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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1a: Monotherapy Dose Escalation 		Participants will receive increasing doses of BG-C0979 as monotherapy.
  • Drug: BG-C0979
    Administered by intravenous infusion.
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.
  • Drug: BG-C0979
    Administered by intravenous infusion.
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.
  • Drug: BG-C0979
    Administered by intravenous infusion.
Experimental
Phase 1b, Part B: Combination Therapy Expansion 		Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.
  • Drug: BG-C0979
    Administered by intravenous infusion.
  • Drug: Tislelizumab
    Administered by intravenous infusion.
    Other names:
    • BGB-A317

Recruiting Locations

Next Oncology San Antonio
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
8778285568
clinicaltrials@beonemed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.