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Study details
Enrolling now

A First-in-human Trial of BGB-53038

BeiGene
NCT IDNCT06585488ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

514

Study length

about 2.1 years

Ages

18+

Locations

4 sites in CA, KS, MD +1

About this study

Researchers are testing a new drug called BGB-53038 to see if it's safe and effective in people with advanced cancers that have KRAS mutations or amplifications. The trial will also explore whether BGB-53038 works better when combined with other medications like tislelizumab or cetuximab.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take BGB-53038
  • 2.Take Cetuximab
  • 3.Take Tislelizumab
PhasePhase 1
DrugCetuximab
Routeinjection
Primary goalPhase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

cetuximab, tislelizumab

Drug routes

injection (Injection)

Endpoints

Primary: Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038, Phase 1a: Number of Participants Experiencing Adverse Events (AEs), Phase 1b: Overall Response Rate (ORR)

Secondary: Disease Control Rate (DCR), Duration of Response (DOR), Phase 1a: Single-dose and steady-state Half-life (t1/2) of BGB-53038, Phase 1a: Single-dose and steady-state area under the concentration-time curve (AUC) of BGB-53038, Phase 1a: Single-dose and steady-state maximum observed plasma concentration (Cmax) of BGB-53038, Phase 1b: Number of Participants Experiencing Adverse Events (AEs), Phase 1b: ORR, Phase 1b: Overall Survival (OS)

Body systems

Oncology