A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
← catalyst calendarSponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.
Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
47actual
Sites
17
Countries
Australia, China, New Zealand +2
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
Why the sponsor stopped it
The Sponsor has made the decision to terminate this study due to the lack of promising efficacy, internal prioritization, and highly competitive landscape.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-13 | actual | When the study began enrolling |
| Primary completion | 2026-04-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-23 | actual | The whole study's end, after follow-up |
| First posted | 2024-09-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Solid Tumors
- Advanced Non-squamous Non-small-cell Lung Cancer
- Advanced Colorectal Cancer
- Advanced Pancreatic Ductal Adenocarcinoma
- Advanced Gastric Cancer
- Advanced Gastroesophageal Junction Cancer
- Advanced Esophageal Adenocarcinoma
Interventions
- Drug: BGB-53038
- Drug: Tislelizumab — also filed as Tevimbra
- Drug: Cetuximab
Primary outcomes
what the primary-completion date above is the date OFPhase 1a: Number of Participants Experiencing Adverse Events (AEs)
measured Up to approximately 2 years
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038
measured Up to approximately 2 years
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-53038
measured Up to approximately 2 years
Phase 1b: Overall Response Rate (ORR)
measured Up to approximately 2 years
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-53038
measured Up to approximately 2 years
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