For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. ≥18 years old
  2. Locally-advanced or metastatic solid tumor with KRAS G12D mutation
  3. For Part 1 and Part 2 Combination Groups 1 and 2: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
  4. For Part 2 Combination Groups 3 and 4: No more than 1 prior standard treatment
  5. Cohort specific requirements as follows:

  1. Parts 1A and 1D: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
  2. Part 1B

  1. Disease group 1: diagnosis of PDAC and ≤ 2 prior standard systemic regimens for pancreatic cancer
  2. Disease group 2: diagnosis of CRC
  3. Disease group 3: diagnosis of NSCLC
  4. Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 or 3
  5. Part 1c: Confirmed diagnosis of PDAC, CRC, or NSCLC
  6. Parts 2A and 2B

* Combination 1: Diagnosis of PDAC or Diagnosis of CRC and


  1. Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and
  2. In Part 2a: ≤ 3 prior standard regimens
  3. In Part 2b: ≤ 2 prior standard regimens
  4. Combination 2: Diagnoses of PDAC, CRC or NSCLC
  5. Combination Group 3 (INCB161734 in combination with GEMNabP) and Combination Group 4 (INCB161734 in combination with mFOLFIRINOX):

  1. Diagnosis of PDAC
  2. ≤ 1 prior standard systemic regimen for pancreatic cancer
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Prior treatment with any KRAS G12D inhibitor
  2. Known additional invasive malignancy within 1 year of the first dose of study drug
  3. History of organ transplant, including allogeneic stem cell transplantation
  4. Significant, uncontrolled medical condition
  5. History or presence of an ECG abnormality
  6. Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1.855.463.3463Email iconEmail Study Center

Study Details


Contition

Solid Tumors

Age

18+

Phase

PHASE1

Participants Needed

466

Est. Completion Date

Jan 1, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Incyte Corporation

ClinicalTrials.gov NCT Identifier

NCT06179160

Study Number

INCB 161734-101

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