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Recruiting Phase 1 NCT06179160

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Phase 1 – testing safety in a small group of people
Conditions: Solid Tumors

Sponsor: Incyte Corporation

trial.available_in: БГ
Overview
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 participate
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
Locations 8
Australia (1)
Chris Obrien Lifehouse
Camperdown , New South Wales
Belgium (1)
Cliniques Universitaires Ucl Saint-Luc
Brussels
Canada (1)
The Ottawa Hospital Cancer Center
Ottawa , Ontario
France (1)
Centre Leon Berard
Lyon
Italy (1)
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan
Japan (1)
National Cancer Center Hospital East
Chiba
Spain (1)
Hospital General Universitario Vall D Hebron
Barcelona
United States (1)
Mayo Clinic Hospital
Phoenix , Arizona
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.01.2024
Completion date
01.01.2027
Registry ID
NCT06179160
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.