Evaluating INCB161734 for advanced solid tumors with KRAS G12D mutation
Official title: A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Run by Incyte Corporation · NCT06179160 · Data updated 2026-11-12
This study is testing a new drug called INCB161734, alone and with other cancer treatments, to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 710 (estimated) |
| Sponsor | Incyte Corporation Industry-sponsored |
| Locations | 34 sites (Phoenix, Arizona and 33 other locations) |
| Status | Recruiting |
| Started | January 4, 2024 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT06179160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with locally-advanced or metastatic solid tumors that have the KRAS G12D mutation.
✕Probably not a fit
Patients without the KRAS G12D mutation or those who have already received multiple lines of treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and tolerability of INCB161734, both as a standalone treatment and in combination with other anticancer therapies, for patients with advanced or metastatic solid tumors harboring the KRAS G12D mutation. Participants will be enrolled based on specific eligibility criteria, including prior treatment history and tumor type. The study will involve various treatment combinations, including INCB161734 with Cetuximab, Retifanlimab, GEMNabP, and mFOLFIRINOX.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors associated with the KRAS G12D mutation.
How similar studies have gone: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be viable and beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Mayo Clinic Hospital
Phoenix, Arizona, United States Recruiting -
Stanford University
Palo Alto, California, United States Recruiting -
UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States Recruiting -
Sarah Cannon Research Institue At Healthone
Denver, Colorado, United States Recruiting -
Florida Cancer Specialists
Sarasota, Florida, United States Recruiting -
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States Recruiting
Show 28 more locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Hackensack University Medical Center
Hackensack, New Jersey, United States Recruiting -
Weill Cornell Medicine
New York, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States Recruiting -
Scri Oncology Partners
Nashville, Tennessee, United States Recruiting -
Md Anderson Cancer Center
Houston, Texas, United States 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
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.