RecruitingPhase 1NCT06179160

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Sponsor

Incyte Corporation

Enrollment

710 participants

Start Date

Jan 4, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumors

Summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called INCB161734 for people whose solid tumors (cancers in organs like the pancreas, colon, or lung) have a specific genetic change called KRAS G12D mutation. This mutation acts like a stuck accelerator in cancer cells, and this drug is designed to block it. **You may be eligible if...** - You are 18 or older with an advanced or metastatic solid tumor - Your tumor has been confirmed to have a KRAS G12D mutation - Your cancer got worse after standard treatments, or standard treatments are not available to you - You are healthy enough to participate (as assessed by your doctor) **You may NOT be eligible if...** - Your tumor does not have the KRAS G12D mutation - You have active brain tumors or serious uncontrolled health conditions - You have had certain prior treatments that would interfere with the study drug - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGINCB161734

INCB161734 will be administered at protocol defined dose.

DRUGCetuximab

Cetuximab will be administered at protocol defined dose.

DRUGRetifanlimab

Retifanlimab will be administered at protocol defined dose.

DRUGGEMNabP

GEMNabP will be administered at protocol defined dose.

DRUGmFOLFIRINOX

mFOLFIRINOX will be administered at protocol defined dose.

DRUGFOLFOX

FOLFOX will be administered at protocol defined dose.

DRUGFOLFIRI

FOLFIRI will be administered at protocol defined dose.

DRUGINCA33890

INCA33890 will be administered at protocol defined dose.

Locations(34)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Stanford University

Palo Alto, California, United States

UCLA Healthcare Hematology-Oncology

Santa Monica, California, United States

Sarah Cannon Research Institue At Healthone

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Weill Cornell Medicine

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Scri Oncology Partners

Nashville, Tennessee, United States

Md Anderson Cancer Center

Houston, Texas, United States

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Peter Maccallum Cancer Centre

North Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Cliniques Universitaires Ucl Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, Belgium

Universitair Ziekenhuis (Uz) Leuven

Leuven, Belgium

The Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Centre Leon Berard

Lyon, France

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy

Irccs Istituto Clinico Humanitas

Rozzano, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

National Cancer Center Hospital East

Chiba, Japan

The Cancer Institute Hospital of Jfcr

Tokyo, Japan

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Quironsalud Madrid

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06179160

Related Trials

5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors

NCT033661161 location

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

NCT0553614125 locations

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

NCT0671013281 locations

A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

NCT045704235 locations

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

NCT03486873779 locations