Not currently recruiting at UCSF

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

a study on Solid Tumor Pancreatic Cancer Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).

Official Title

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Keywords

Solid Tumors, INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), KRAS G12D inhibitor, KRAS inhibitor, KRAS mutation, pancreatic cancer, metastatic pancreatic cancer, Pancreatic Neoplasms, INCB161734 plus chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation
  • No prior systemic treatment in the metastatic setting
  • ECOG Performance status 0-1
  • Adequate organ function

You CAN'T join if...

  • Prior treatment with any KRAS inhibitor
  • Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug
  • Known active CNS metastases

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations

  • Investigative Site US034 not yet accepting patients
    San Francisco California 94143 United States
  • Investigative Site US084 not yet accepting patients
    Reno Nevada 89502 United States
  • Investigative Site US036 accepting new patients
    Los Angeles California 90089 United States
  • Investigative Site US027 accepting new patients
    Riverside California 92505 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
ID
NCT07522073
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 588 study participants
Last Updated