Recruiting
Phase 1

INCB161734

Sponsor:

Incyte Corporation

Code:

NCT06179160

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCB161734

Cetuximab

Retifanlimab

GEMNabP

mFOLFIRINOX

Study Details

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

Study ID

NCT06179160

Start date

Jan 4, 2024

Status verified date

Jul, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

710 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a: Dose Escalation monotherapy

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

experimental: Part 1b: Dose Expansion monotherapy

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

experimental: Part 1c: Pharmacodynamic cohort

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

experimental: Part 2a: Dose Escalation combination

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

experimental: Part 2b: Dose Expansion combination

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

experimental: Part 1d: Food-Effect

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

Interventions

INCB161734

INCB161734 will be administered at protocol defined dose.

Cetuximab

Cetuximab will be administered at protocol defined dose.

Retifanlimab

Retifanlimab will be administered at protocol defined dose.

GEMNabP

GEMNabP will be administered at protocol defined dose.

mFOLFIRINOX

mFOLFIRINOX will be administered at protocol defined dose.

FOLFOX

FOLFOX will be administered at protocol defined dose.

FOLFIRI

FOLFIRI will be administered at protocol defined dose.

INCA33890

INCA33890 will be administered at protocol defined dose.

Primary outcome measure

  • Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years and 90 days ]
  • Number of participants with TEAEs leading to dose modification or discontinuation [ Time Frame: Up to 2 years and 90 days ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Stanford University

Recruiting

Palo Alto, California, United States, 94305

UCLA Healthcare Hematology-Oncology

Recruiting

Santa Monica, California, United States, 90404

Sarah Cannon Research Institue At Healthone

Recruiting

Denver, Colorado, United States, 80218

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10022

Jefferson University Hospitals

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Scri Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

The Ottawa Hospital Cancer Center

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Incyte Corporation

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-07-22.