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

Recruiting now · Phase 1

Conditions studied: Solid Tumors

In brief

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

Key facts

Study ID

NCT06179160

Run by

Incyte Corporation

People needed

710

Starts

2024-01-04

Expected to finish

2027-01-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• UCLA Healthcare Hematology-Oncology — Santa Monica, California, United States (enrolling)
• Sarah Cannon Research Institue At Healthone — Denver, Colorado, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Jefferson University Hospitals — Philadelphia, Pennsylvania, United States (enrolling)
• Scri Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Chris Obrien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
• St Vincent'S Hospital Sydney — Darlinghurst, New South Wales, Australia (enrolling)
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Cliniques Universitaires Ucl Saint-Luc — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Antwerpen (Uza) — Edegem, Belgium (enrolling)
• Universitair Ziekenhuis (Uz) Leuven — Leuven, Belgium (enrolling)
• The Ottawa Hospital Cancer Center — Ottawa, Ontario, Canada (enrolling)
• Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)
• Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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