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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1a: Dose Escalation monotherapy 		INCB161734 at the protocol-defined dose strength based on cohort assignment.
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.
Experimental
Part 1b: Dose Expansion monotherapy 		INCB161734 at the protocol-defined dose strength based on cohort assignment.
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.
Experimental
Part 1c: Pharmacodynamic cohort 		INCB161734 at the protocol-defined dose strength based on cohort assignment.
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.
Experimental
Part 2a: Dose Escalation combination 		INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.
  • Drug: Cetuximab
    Cetuximab will be administered at protocol defined dose.
  • Drug: Retifanlimab
    Retifanlimab will be administered at protocol defined dose.
  • Drug: GEMNabP
    GEMNabP will be administered at protocol defined dose.
  • Drug: mFOLFIRINOX
    mFOLFIRINOX will be administered at protocol defined dose.
  • Drug: FOLFOX
    FOLFOX will be administered at protocol defined dose.
  • Drug: FOLFIRI
    FOLFIRI will be administered at protocol defined dose.
  • Drug: INCA33890
    INCA33890 will be administered at protocol defined dose.
Experimental
Part 2b: Dose Expansion combination 		INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.
  • Drug: Cetuximab
    Cetuximab will be administered at protocol defined dose.
  • Drug: Retifanlimab
    Retifanlimab will be administered at protocol defined dose.
  • Drug: GEMNabP
    GEMNabP will be administered at protocol defined dose.
  • Drug: mFOLFIRINOX
    mFOLFIRINOX will be administered at protocol defined dose.
  • Drug: FOLFOX
    FOLFOX will be administered at protocol defined dose.
  • Drug: FOLFIRI
    FOLFIRI will be administered at protocol defined dose.
  • Drug: INCA33890
    INCA33890 will be administered at protocol defined dose.
Experimental
Part 1d: Food-Effect 		Evaluate food effect on drug exposure as defined in the protocol.
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.

Recruiting Locations

Mayo Clinic Hospital
Phoenix 5308655, Arizona 5551752 85054

Stanford University
Palo Alto 5380748, California 5332921 94305

UCLA Healthcare Hematology-Oncology
Santa Monica 5393212, California 5332921 90404

Sarah Cannon Research Institue At Healthone
Denver 5419384, Colorado 5417618 80218

Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore 4347778, Maryland 4361885 21287

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

Weill Cornell Medicine
New York 5128581, New York 5128638 10021

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10022

Scri Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.