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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
NCT06179160 · Incyte Corporation
In plain English
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Official title
A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
About this study
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
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
Study design
Enrollment target: 710 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-04
Estimated completion: 2027-01-01
Last updated: 2026-03-16
Interventions
Drug: INCB161734Drug: CetuximabDrug: RetifanlimabDrug: GEMNabPDrug: mFOLFIRINOXDrug: FOLFOXDrug: FOLFIRIDrug: INCA33890
Primary outcomes
- • Number of participants with Dose Limiting Toxicities (DLTs) (Up to 28 days)
- • Number of participants with Treatment-emergent Adverse Events (TEAEs) (Up to 2 years and 90 days)
- • Number of participants with TEAEs leading to dose modification or discontinuation (Up to 2 years and 90 days)
Sponsor
Incyte Corporation · industry
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
InvestigatorIncyte Medical Monitor · study_director, Incyte Corporation
All locations (34)
Mayo Clinic HospitalRecruiting
Phoenix, Arizona, United States
Stanford UniversityRecruiting
Palo Alto, California, United States
UCLA Healthcare Hematology-OncologyRecruiting
Santa Monica, California, United States
Sarah Cannon Research Institue At HealthoneRecruiting
Denver, Colorado, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsRecruiting
Baltimore, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Jefferson University HospitalsRecruiting
Philadelphia, Pennsylvania, United States
Scri Oncology PartnersRecruiting
Nashville, Tennessee, United States
Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Chris Obrien LifehouseRecruiting
Camperdown, New South Wales, Australia
St Vincent'S Hospital SydneyRecruiting
Darlinghurst, New South Wales, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Peter Maccallum Cancer CentreRecruiting
North Melbourne, Victoria, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Cliniques Universitaires Ucl Saint-LucRecruiting
Brussels, Belgium
Universitair Ziekenhuis Antwerpen (Uza)Recruiting
Edegem, Belgium
Universitair Ziekenhuis (Uz) LeuvenRecruiting
Leuven, Belgium
The Ottawa Hospital Cancer CenterRecruiting
Ottawa, Ontario, Canada
Princess Margaret Cancer CenterRecruiting
Toronto, Ontario, Canada
Centre Leon BerardRecruiting
Lyon, France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleRecruiting
Toulouse, France
Institut Gustave RoussyRecruiting
Villejuif, France
Fondazione Irccs Istituto Nazionale Dei TumoriRecruiting
Milan, Italy
Irccs Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Centro Ricerche Cliniche Di VeronaRecruiting
Verona, Italy
National Cancer Center Hospital EastRecruiting
Chiba, Japan
The Cancer Institute Hospital of JfcrRecruiting
Tokyo, Japan
Hospital General Universitario Vall D HebronRecruiting
Barcelona, Spain
Fundacion Jimenez DiazRecruiting
Madrid, Spain
Hospital Universitario Quironsalud MadridRecruiting
Madrid, Spain