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A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

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NCT06422520

Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.

Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
63actual
Sites
14
Countries
Australia, China, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-07-08actualWhen the study began enrolling
Primary completion2026-05-15actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-05-15actualThe whole study's end, after follow-up
First posted2024-05-21actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-08actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Advanced Solid Tumor

Interventions

  • Drug: BGB-C354
  • Drug: Tislelizumab

Primary outcomes

what the primary-completion date above is the date OF
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Approximately 24 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354
measured Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
measured Approximately 24 months
Phase 1b: Overall Response Rate (ORR)
measured Approximately 24 months
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab
measured Approximately 24 months

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