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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT06179160
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Jan 4, 2024
Status verified
Apr 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
710 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Stanford UniversityPalo AltoCalifornia94305-
UCLA Healthcare Hematology-OncologySanta MonicaCalifornia90404-
Sarah Cannon Research Institue At HealthoneDenverColorado80218-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Florida Cancer SpecialistsSarasotaFlorida34232-
Florida Cancer SpecialistsSarasotaFlorida34232-
Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10022-
Weill Cornell MedicineNew YorkNew York10021-
Jefferson University HospitalsPhiladelphiaPennsylvania19107-
Scri Oncology PartnersNashvilleTennessee37203-
Md Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZStanford University· Palo Alto, CAUCLA Healthcare Hematology-Oncology· Santa Monica, CASarah Cannon Research Institue At Healthone· Denver, COMayo Clinic Florida· Jacksonville, FLFlorida Cancer Specialists· Sarasota, FL

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