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NCT06179160PHASE1Recruiting

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

Incyte Corporation

Start Date

1/4/2024

Completion Date

1/1/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥18 years old. * Locally advanced or metastatic solid tumor with KRAS G12D mutation. * For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome. * Cohort specific requirements aas defined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Prior treatment with any KRAS G12D inhibitor * Known additional invasive malignancy within 1 year of the first dose of study drug * History of organ transplant, including allogeneic stem cell transplantation * Significant, uncontrolled medical condition * History or presence of an ECG abnormality * Inadequate organ function Other protocol-defined Inclusion/Exclusion Criteria may apply

Interventions

DRUG

INCB161734

DRUG

Cetuximab

DRUG

Retifanlimab

DRUG

GEMNabP

DRUG

mFOLFIRINOX

DRUG

FOLFOX

DRUG

FOLFIRI

DRUG

INCA33890

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Conditions

Solid Tumors

Locations

Mayo Clinic Hospital

Phoenix, Arizona 85054

United States

Stanford University

Palo Alto, California 94305

United States

UCLA Healthcare Hematology-Oncology

Santa Monica, California 90404

United States

Sarah Cannon Research Institue At Healthone

Denver, Colorado 80218

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland 21287

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Weill Cornell Medicine

New York, New York 10021

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10022

United States

Jefferson University Hospitals

Philadelphia, Pennsylvania 19107

United States

Scri Oncology Partners

Nashville, Tennessee 37203

United States

Md Anderson Cancer Center

Houston, Texas 77030

United States

Chris Obrien Lifehouse

Camperdown, New South Wales 02050

Australia

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales 02010

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria 03000

Australia

The Alfred Hospital

Melbourne, Victoria 03004

Australia

Linear Clinical Research

Nedlands, Western Australia 06009

Australia

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200

Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650

Belgium

Universitair Ziekenhuis (Uz) Leuven

Leuven, 03000

Belgium

The Ottawa Hospital Cancer Center

Ottawa, Ontario K1H 8L6

Canada

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

Centre Leon Berard

Lyon, 69373

France

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, 31059

France

Institut Gustave Roussy

Villejuif, 94805

France

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133

Italy

Irccs Istituto Clinico Humanitas

Rozzano, 20089

Italy

Centro Ricerche Cliniche Di Verona

Verona, 37134

Italy

National Cancer Center Hospital East

Chiba, 277-0882

Japan

The Cancer Institute Hospital of Jfcr

Tokyo, 135-0063

Japan

Hospital General Universitario Vall D Hebron

Barcelona, 08035

Spain

Fundacion Jimenez Diaz

Madrid, 28040

Spain

Hospital Universitario Quironsalud Madrid

Madrid, 28223

Spain