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NCT Number: NCT06179160

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

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

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Key information

Conditions

Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chris Obrien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INCB161734

Drug

INCB161734 will be administered at protocol defined dose.

Cetuximab

Drug

Cetuximab will be administered at protocol defined dose.

Retifanlimab

Drug

Retifanlimab will be administered at protocol defined dose.

GEMNabP

Drug

GEMNabP will be administered at protocol defined dose.

mFOLFIRINOX

Drug

mFOLFIRINOX will be administered at protocol defined dose.

FOLFOX

Drug

FOLFOX will be administered at protocol defined dose.

FOLFIRI

Drug

FOLFIRI will be administered at protocol defined dose.

INCA33890

Drug

INCA33890 will be administered at protocol defined dose.

Primary outcomes

  1. Number of participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 28 days

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

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

    Time frame: Up to 2 years and 90 days

    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.

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

    Time frame: Up to 2 years and 90 days

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

Secondary outcomes

  1. INCB161734 pharmacokinetic (PK) in Plasma

    Time frame: Up to approximately 90 days

    INCB161734 concentration in plasma.

  2. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

  3. Disease Control Response (DCR)

    Time frame: Up to 2 years

    Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

  4. Duration of Response (DOR)

    Time frame: Up to 2 years

    Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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