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

Summary

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

Interventions

• INCB161734 · DRUG

  INCB161734 will be administered at protocol defined dose.

• Cetuximab · DRUG

  Cetuximab will be administered at protocol defined dose.

• Retifanlimab · DRUG

  Retifanlimab will be administered at protocol defined dose.

• GEMNabP · DRUG

  GEMNabP will be administered at protocol defined dose.

• mFOLFIRINOX · DRUG

  mFOLFIRINOX will be administered at protocol defined dose.

• FOLFOX · DRUG

  FOLFOX will be administered at protocol defined dose.

• FOLFIRI · DRUG

  FOLFIRI will be administered at protocol defined dose.

• INCA33890 · DRUG

  INCA33890 will be administered at protocol defined dose.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (34)

• Mayo Clinic Hospital, Phoenix, Arizona · RECRUITING
• Stanford University, Palo Alto, California · RECRUITING
• UCLA Healthcare Hematology-Oncology, Santa Monica, California · RECRUITING
• Sarah Cannon Research Institue At Healthone, Denver, Colorado · RECRUITING
• Florida Cancer Specialists, Sarasota, Florida · RECRUITING
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland · RECRUITING
• Dana Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• Hackensack University Medical Center, Hackensack, New Jersey · RECRUITING
• Weill Cornell Medicine, New York, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• Jefferson University Hospitals, Philadelphia, Pennsylvania · RECRUITING
• Scri Oncology Partners, Nashville, Tennessee · RECRUITING
• Md Anderson Cancer Center, Houston, Texas · RECRUITING
• Chris Obrien Lifehouse, Camperdown, New South Wales, Australia · RECRUITING
• St Vincent'S Hospital Sydney, Darlinghurst, New South Wales, Australia · RECRUITING
• Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia · RECRUITING
• The Alfred Hospital, Melbourne, Victoria, Australia · RECRUITING
• Linear Clinical Research, Nedlands, Western Australia, Australia · RECRUITING
• Cliniques Universitaires Ucl Saint-Luc, Brussels, Belgium · RECRUITING
• Universitair Ziekenhuis Antwerpen (Uza), Edegem, Belgium · RECRUITING
• Universitair Ziekenhuis (Uz) Leuven, Leuven, Belgium · RECRUITING
• The Ottawa Hospital Cancer Center, Ottawa, Ontario, Canada · RECRUITING
• Princess Margaret Cancer Center, Toronto, Ontario, Canada · RECRUITING
• Centre Leon Berard, Lyon, France · RECRUITING
• Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole, Toulouse, France · RECRUITING
• Institut Gustave Roussy, Villejuif, France · RECRUITING
• Fondazione Irccs Istituto Nazionale Dei Tumori, Milan, Italy · RECRUITING
• Irccs Istituto Clinico Humanitas, Rozzano, Italy · RECRUITING
• Centro Ricerche Cliniche Di Verona, Verona, Italy · RECRUITING
• National Cancer Center Hospital East, Chiba, Japan · RECRUITING
• The Cancer Institute Hospital of Jfcr, Tokyo, Japan · RECRUITING
• Hospital General Universitario Vall D Hebron, Barcelona, Spain · RECRUITING
• Fundacion Jimenez Diaz, Madrid, Spain · RECRUITING
• Hospital Universitario Quironsalud Madrid, Madrid, Spain · RECRUITING