A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Recruiting · NCT06179160 · Interventional (participants receive a specific treatment) · Lead sponsor: Incyte Corporation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
- ther protocol-defined Inclusion/Exclusion Criteria may apply
Where it is running
34 locations listed across 11 US states.
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- Stanford University - Palo Alto, California, United States
- UCLA Healthcare Hematology-Oncology - Santa Monica, California, United States
- Sarah Cannon Research Institue At Healthone - Denver, Colorado, United States
- Florida Cancer Specialists - Sarasota, Florida, United States
- Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins - Baltimore, Maryland, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- Weill Cornell Medicine - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Jefferson University Hospitals - Philadelphia, Pennsylvania, United States
- Scri Oncology Partners - Nashville, Tennessee, United States
- Md Anderson Cancer Center - Houston, Texas, United States
- Hospital General Universitario Vall D Hebron - Barcelona, Spain
- Cliniques Universitaires Ucl Saint-Luc - Brussels, Belgium
- National Cancer Center Hospital East - Chiba, Japan
- Universitair Ziekenhuis Antwerpen (Uza) - Edegem, Belgium
- Universitair Ziekenhuis (Uz) Leuven - Leuven, Belgium
- Centre Leon Berard - Lyon, France
- Fundacion Jimenez Diaz - Madrid, Spain
- Hospital Universitario Quironsalud Madrid - Madrid, Spain
- Fondazione Irccs Istituto Nazionale Dei Tumori - Milan, Italy
- Irccs Istituto Clinico Humanitas - Rozzano, Italy
- The Cancer Institute Hospital of Jfcr - Tokyo, Japan
- Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole - Toulouse, France
- Centro Ricerche Cliniche Di Verona - Verona, Italy
- Institut Gustave Roussy - Villejuif, France
- Chris Obrien Lifehouse - Camperdown, New South Wales, Australia
- St Vincent'S Hospital Sydney - Darlinghurst, New South Wales, Australia
- The Ottawa Hospital Cancer Center - Ottawa, Ontario, Canada
- Princess Margaret Cancer Center - Toronto, Ontario, Canada
- Peter Maccallum Cancer Centre - Melbourne, Victoria, Australia
- The Alfred Hospital - Melbourne, Victoria, Australia
- Linear Clinical Research - Nedlands, Western Australia, Australia