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

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

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

Eligibility criteria

Qualifiers

≥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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • INCB161734
  • Cetuximab
  • Retifanlimab
  • GEMNabP
  • mFOLFIRINOX
  • FOLFOX
  • FOLFIRI
  • INCA33890

Treatment groups

710 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators