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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

NCT06585488 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2026-03-18

No results posted yet for this study

Summary

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

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

Administered orally

DRUG

Tislelizumab

administered by intravenous infusion

DRUG

Cetuximab

administered by intravenous infusion

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-26
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • New Zealand
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585488 on ClinicalTrials.gov