Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chris Obrien Lifehouse
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
St Vincent's Hospital Sydney
Coordinator of this site? Confirm its status
DarlinghurstAustraliaRecruiting
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
The Alfred Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Linear Clinical Research
Coordinator of this site? Confirm its status
NedlandsAustraliaRecruiting
Cliniques Universitaires Ucl Saint-Luc
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
Universitair Ziekenhuis Antwerpen (Uza)
Coordinator of this site? Confirm its status
EdegemBelgiumRecruiting
Universitair Ziekenhuis (Uz) Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
The Ottawa Hospital Cancer Center
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Princess Margaret Cancer Center
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Hospital General Universitario Vall D Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Quirónsalud Madrid
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IRCCS Istituto Clinico Humanitas
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting
Centro Ricerche Cliniche Di Verona
Coordinator of this site? Confirm its status
VeronaItalyRecruiting
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
ChibaJapanRecruiting
The Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Sarah Cannon Research Institue At Healthone
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
SCRI Oncology Partners
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Stanford University
Coordinator of this site? Confirm its status
Palo AltoUnited StatesRecruiting
Jefferson University Hospitals
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
UCLA Healthcare Hematology-Oncology
Coordinator of this site? Confirm its status
Santa MonicaUnited StatesRecruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
SarasotaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.