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

NCT ID: NCT06179160

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

710 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-04

Study Completion Date

2027-01-01

Brief Summary

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

Detailed Description

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Conditions

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Solid Tumors

Keywords

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INCB161734 KRASG12D Mutation pancreatic ductal adenocarcinoma (PDAC) colorectal cancer (CRC) non-small cell lung cancer (NSCLC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1a: Dose Escalation monotherapy

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group Type EXPERIMENTAL

INCB161734

Intervention Type DRUG

INCB161734 will be administered at protocol defined dose.

Part 1b: Dose Expansion monotherapy

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group Type EXPERIMENTAL

INCB161734

Intervention Type DRUG

INCB161734 will be administered at protocol defined dose.

Part 1c: Pharmacodynamic cohort

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group Type EXPERIMENTAL

INCB161734

Intervention Type DRUG

INCB161734 will be administered at protocol defined dose.

Part 2a: Dose Escalation combination

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Group Type EXPERIMENTAL

INCB161734

Intervention Type DRUG

INCB161734 will be administered at protocol defined dose.

Cetuximab

Intervention Type DRUG

Cetuximab will be administered at protocol defined dose.

Retifanlimab

Intervention Type DRUG

Retifanlimab will be administered at protocol defined dose.

GEMNabP

Intervention Type DRUG

GEMNabP will be administered at protocol defined dose.

mFOLFIRINOX

Intervention Type DRUG

mFOLFIRINOX will be administered at protocol defined dose.

FOLFOX

Intervention Type DRUG

FOLFOX will be administered at protocol defined dose.

FOLFIRI

Intervention Type DRUG

FOLFIRI will be administered at protocol defined dose.

INCA33890

Intervention Type DRUG

INCA33890 will be administered at protocol defined dose.

Part 2b: Dose Expansion combination

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Group Type EXPERIMENTAL

INCB161734

Intervention Type DRUG

INCB161734 will be administered at protocol defined dose.

Cetuximab

Intervention Type DRUG

Cetuximab will be administered at protocol defined dose.

Retifanlimab

Intervention Type DRUG

Retifanlimab will be administered at protocol defined dose.

GEMNabP

Intervention Type DRUG

GEMNabP will be administered at protocol defined dose.

mFOLFIRINOX

Intervention Type DRUG

mFOLFIRINOX will be administered at protocol defined dose.

FOLFOX

Intervention Type DRUG

FOLFOX will be administered at protocol defined dose.

FOLFIRI

Intervention Type DRUG

FOLFIRI will be administered at protocol defined dose.

INCA33890

Intervention Type DRUG

INCA33890 will be administered at protocol defined dose.

Part 1d: Food-Effect

Evaluate food effect on drug exposure as defined in the protocol.

Group Type EXPERIMENTAL

INCB161734

Intervention Type DRUG

INCB161734 will be administered at protocol defined dose.

Interventions

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INCB161734

INCB161734 will be administered at protocol defined dose.

Intervention Type DRUG

Cetuximab

Cetuximab will be administered at protocol defined dose.

Intervention Type DRUG

Retifanlimab

Retifanlimab will be administered at protocol defined dose.

Intervention Type DRUG

GEMNabP

GEMNabP will be administered at protocol defined dose.

Intervention Type DRUG

mFOLFIRINOX

mFOLFIRINOX will be administered at protocol defined dose.

Intervention Type DRUG

FOLFOX

FOLFOX will be administered at protocol defined dose.

Intervention Type DRUG

FOLFIRI

FOLFIRI will be administered at protocol defined dose.

Intervention Type DRUG

INCA33890

INCA33890 will be administered at protocol defined dose.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Stanford University

Palo Alto, California, United States

Site Status RECRUITING

UCLA Healthcare Hematology-Oncology

Santa Monica, California, United States

Site Status RECRUITING

Sarah Cannon Research Institue At Healthone

Denver, Colorado, United States

Site Status RECRUITING

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status NOT_YET_RECRUITING

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Jefferson University Hospitals

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Scri Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

Md Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

Site Status RECRUITING

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Peter Maccallum Cancer Centre

North Melbourne, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status RECRUITING

Cliniques Universitaires Ucl Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis (Uz) Leuven

Leuven, , Belgium

Site Status RECRUITING

The Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, , Italy

Site Status RECRUITING

Irccs Istituto Clinico Humanitas

Rozzano, , Italy

Site Status RECRUITING

Centro Ricerche Cliniche Di Verona

Verona, , Italy

Site Status RECRUITING

National Cancer Center Hospital East

Chiba, , Japan

Site Status RECRUITING

The Cancer Institute Hospital of Jfcr

Tokyo, , Japan

Site Status RECRUITING

Hospital General Universitario Vall D Hebron

Barcelona, , Spain

Site Status RECRUITING

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Quironsalud Madrid

Madrid, , Spain

Site Status RECRUITING

Countries

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United States Australia Belgium Canada France Italy Japan Spain

Central Contacts

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Incyte Corporation Call Center (US)

Role: CONTACT

Phone: 1.855.463.3463

Email: [email protected]

Incyte Corporation Call Center (ex-US)

Role: CONTACT

Phone: +800 00027423

Email: [email protected]

Related Links

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https://incyteclinicaltrials.com/studies/incb161734-101

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

Other Identifiers

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2023-507091-47-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCB161734-101

Identifier Type: -

Identifier Source: org_study_id