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RECRUITING
NCT06585488
PHASE1

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

Sponsor: BeiGene

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

514

Start Date

2024-11-26

Completion Date

2026-12

Last Updated

2026-03-18

Healthy Volunteers

Yes

Interventions

DRUG

BGB-53038

Administered orally

DRUG

Tislelizumab

administered by intravenous infusion

DRUG

Cetuximab

administered by intravenous infusion

Locations (17)

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Auckland City Hospital

Auckland, New Zealand

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea