Trials / Recruiting

RecruitingNCT06585488

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

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplifications

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 514 (estimated)

Sponsor: BeiGene · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BGB-53038	Administered orally
DRUG	Tislelizumab	administered by intravenous infusion
DRUG	Cetuximab	administered by intravenous infusion

Timeline

Start date: 2024-11-26
Primary completion: 2026-12-01
Completion: 2026-12-01
First posted: 2024-09-05
Last updated: 2026-03-18

Locations

17 sites across 5 countries: United States, Australia, China, New Zealand, South Korea

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06585488. Inclusion in this directory is not an endorsement.