Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion 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), Neoplasms, Cetuximab, Retifanlimab

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
  • Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
  • Cohort specific requirements as follows:
    • Part 1A: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
    • Part 1B
      • Disease group 1: diagnosis of PDAC
      • Disease group 2: diagnosis of CRC
      • Disease group 3: diagnosis of NSCLC
      • Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 and 3
    • Parts 2A and 2B
      • Combination 1: Diagnosis of CRC or CRC
      • Combination 2: Diagnoses of PDAC, CRC or NSCLC
  • 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 not yet accepting patients
    Santa Monica California 90404 United States
  • Mayo Clinic Hospital not yet accepting patients
    Phoenix Arizona 85054 United States
  • Hackensack University Medical Center accepting new patients
    Hackensack New Jersey 07601 United States
  • St Vincent'S Hospital Sydney accepting new patients
    Darlinghurst New South Wales 02010 Australia
  • The Alfred Hospital accepting new patients
    Melbourne Victoria 03004 Australia
  • Peter Maccallum Cancer Centre accepting new patients
    North Melbourne Victoria 3051 Australia
  • Linear Clinical Research accepting new patients
    Nedlands Western Australia 06009 Australia

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT06179160
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 322 study participants
Last Updated