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

a study on Solid Tumor Colorectal Cancer Colorectal Tumor Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Official Title

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Keywords

Solid Tumors, INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), Colorectal Neoplasms, Non-Small-Cell Lung Carcinoma, Cetuximab, Folfox protocol, IFL protocol, Retifanlimab, GEMNabP, mFOLFIRINOX, FOLFOX, FOLFIRI, INCA33890, Food-Effect

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥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.

You CAN'T join if...

  • 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

  • UCLA Healthcare Hematology-Oncology accepting new patients
    Santa Monica 5393212 California 5332921 90404 United States
  • Stanford University accepting new patients
    Palo Alto 5380748 California 5332921 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT06179160
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 710 study participants
Last Updated