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

NCT06179160 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: INCB161734-1012023-507091-47-00
• Study Type: interventional
• Target: 710
• Locations: 8 countries
• Sites: 37

Brief Summary

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

Conditions

Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of participants with Dose Limiting Toxicities (DLTs)

  Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

  Up to 28 days

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.

  Up to 2 years and 90 days

• Number of participants with TEAEs leading to dose modification or discontinuation

  Number of participants with TEAEs leading to dose modification or discontinuation.

  Up to 2 years and 90 days

Secondary Outcomes (4)

• INCB161734 pharmacokinetic (PK) in Plasma

  Up to approximately 90 days

• Objective Response Rate (ORR)

  Up to 2 years

• Disease Control Response (DCR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

Study Arms (6)

Part 1a: Dose Escalation monotherapy

EXPERIMENTAL

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

Drug: INCB161734

Part 1b: Dose Expansion monotherapy

EXPERIMENTAL

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

Drug: INCB161734

Part 1c: Pharmacodynamic cohort

EXPERIMENTAL

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

Drug: INCB161734

Part 2a: Dose Escalation combination

EXPERIMENTAL

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

Drug: INCB161734; Drug: Cetuximab; Drug: Retifanlimab; Drug: GEMNabP; Drug: mFOLFIRINOX; Drug: FOLFOX; Drug: FOLFIRI; Drug: INCA33890

Part 2b: Dose Expansion combination

EXPERIMENTAL

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

Drug: INCB161734; Drug: Cetuximab; Drug: Retifanlimab; Drug: GEMNabP; Drug: mFOLFIRINOX; Drug: FOLFOX; Drug: FOLFIRI; Drug: INCA33890

Part 1d: Food-Effect

EXPERIMENTAL

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

Drug: INCB161734

Interventions

INCB161734 DRUG

INCB161734 will be administered at protocol defined dose.

Part 1a: Dose Escalation monotherapy; Part 1b: Dose Expansion monotherapy; Part 1c: Pharmacodynamic cohort; Part 1d: Food-Effect; Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

Cetuximab DRUG

Cetuximab will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

Retifanlimab DRUG

Retifanlimab will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

GEMNabP DRUG

GEMNabP will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

mFOLFIRINOX DRUG

mFOLFIRINOX will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

FOLFOX DRUG

FOLFOX will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

FOLFIRI DRUG

FOLFIRI will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

INCA33890 DRUG

INCA33890 will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (37)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

RECRUITING

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

UCLA Healthcare Hematology-Oncology

Santa Monica, California, 90404, United States

RECRUITING

Sarah Cannon Research Institue At Healthone

Denver, Colorado, 80218, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

WITHDRAWN

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

WITHDRAWN

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

WITHDRAWN

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

RECRUITING

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Scri Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Md Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Chris Obrien Lifehouse

Camperdown, New South Wales, 02050, Australia

RECRUITING

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, 02010, Australia

RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, 03000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 03004, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 06009, Australia

RECRUITING

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650, Belgium

RECRUITING

Universitair Ziekenhuis (Uz) Leuven

Leuven, 03000, Belgium

RECRUITING

The Ottawa Hospital Cancer Center

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

RECRUITING

Irccs Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Centro Ricerche Cliniche Di Verona

Verona, 37134, Italy

RECRUITING

National Cancer Center Hospital East

Chiba, 277-0882, Japan

RECRUITING

The Cancer Institute Hospital of Jfcr

Tokyo, 135-0063, Japan

RECRUITING

Hospital General Universitario Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

COMPLETED

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Folfox protocol; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: January 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); CA (2); IT (3); BE (3); JP (2); AU (5); FR (3); US (16)