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. * Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
  4. * Cohort specific requirements as follows:
  1. * Part 1A: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
  2. * Part 1B
  1. * Disease group 1: diagnosis of PDAC
  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 and 3
  5. * Parts 2A and 2B
  1. * Combination 1: Diagnosis of CRC or CRC
  2. * Combination 2: Diagnoses of PDAC, CRC or NSCLC
  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 (in years)
18+
Phase
PHASE1
Participants Needed
322
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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