NCT06179160RecruitingPhase 1
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 710 (estimated)
- First submitted
- 12 Dec 2023
- Start date
- 4 Jan 2024
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Incyte Corporation
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT06179160
- EU CT number
- 2023-507091-47-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 710
- From 4 Jan 2024 to the primary completion date, 1 Jan 2027
- 34 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any KRAS G12D inhibitor
Other illness
- 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
Other
- History or presence of an ECG abnormality
- Inadequate organ function
- Other protocol-defined Inclusion/Exclusion Criteria may apply
Who the study is looking for
- ≥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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris Obrien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Cliniques Universitaires Ucl Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen (Uza) Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis (Uz) Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| The Ottawa Hospital Cancer Center Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital General Universitario Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Quirónsalud Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Centro Ricerche Cliniche Di Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Sarah Cannon Research Institue At Healthone Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Jefferson University Hospitals Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| UCLA Healthcare Hematology-Oncology Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.