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RecruitingPhase 1NCT06585488

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

Sponsor

BeiGene

Enrollment

514 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Gastric CancerMetastatic Solid TumorsAdvanced Non-squamous Non-small-cell Lung CancerAdvanced Colorectal CancerAdvanced Pancreatic Ductal AdenocarcinomaAdvanced Gastroesophageal Junction CancerAdvanced Esophageal Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study is testing a new experimental drug called BGB-53038, which is designed to block a protein called KRAS — one of the most common cancer-causing mutations. The drug is being tested alone and in combination with other treatments in patients with advanced solid tumors that carry KRAS mutations. **You may be eligible if...** - You have an advanced or metastatic solid tumor with a confirmed KRAS mutation or amplification (detected from tumor tissue or a blood test) - Your cancer has progressed after at least one prior standard treatment - Your overall health is rated 0 or 1 on standard performance scales - Your major organ functions are within acceptable ranges **You may NOT be eligible if...** - You have untreated or unstable brain metastases - You have significant heart disease or recent heart attack - You are currently taking medications that strongly interact with the study drug - You are pregnant or breastfeeding - You have active autoimmune conditions requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-53038

Administered orally

DRUGTislelizumab

administered by intravenous infusion

DRUGCetuximab

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

View Full Details on ClinicalTrials.gov

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NCT06585488

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