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NCT07522073Recruiting

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

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).

Inclusion criteria

• 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

Exclusion criteria

• 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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Canada, Denmark, Finland, Georgia, Japan, Netherlands, New Zealand, Norway, Poland, Puerto Rico, South Korea, Spain, Sweden, United Kingdom
Sponsor
Incyte Corporation(Industry)
Protocol no.
INCB161734-303
Conditions
Solid Tumors
Interventions
Drug

Treatments studied

  • INCB161734
  • Placebo
  • Investigator's choice of chemotherapy

Collaborators

Qiagen Manchester Ltd

Locations · 106

  • Basel, SwitzerlandInvestigative Site CH005Recruiting at this site
  • Bochum, GermanyInvestigative Site DE003Recruiting at this site
  • Freiburg im Breisgau, GermanyInvestigative Site DE016Recruiting at this site
  • Hamburg, GermanyInvestigative Site DE007Recruiting at this site
  • Hamburg, GermanyInvestigative Site DE006Recruiting at this site
  • München, GermanyInvestigative Site DE014Recruiting at this site
  • Nuremberg, GermanyInvestigative Site DE010Recruiting at this site
  • Ulm, GermanyInvestigative Site DE011Recruiting at this site
  • Brescia, ItalyInvestigative Site IT010Recruiting at this site
  • Candiolo, ItalyInvestigative Site IT009Recruiting at this site
  • Verona, ItalyInvestigative Site IT007Recruiting at this site
  • Innsbruck, AustriaInvestigative Site AT002Recruiting at this site
  • Linz, AustriaInvestigative Site AT004Recruiting at this site
  • Salzburg, AustriaInvestigative Site AT003Recruiting at this site
  • Anchorage, United StatesInvestigative Site US016Recruiting at this site
  • Chandler, United StatesInvestigative Site US026Recruiting at this site
  • Duarte, United StatesInvestigative Site US051Recruiting at this site
  • Los Angeles, United StatesInvestigative Site US027Recruiting at this site
  • Los Angeles, United StatesInvestigative Site US036Recruiting at this site
  • Los Angeles, United StatesInvestigative Site US048Recruiting at this site
  • Orange, United StatesInvestigative Site US049Recruiting at this site
  • San Francisco, United StatesInvestigative Site US034Recruiting at this site
  • Santa Monica, United StatesInvestigative Site US001Recruiting at this site
  • Denver, United StatesInvestigative Site US071Recruiting at this site
  • Fort Myers, United StatesInvestigative Site US072Recruiting at this site
  • Miami, United StatesInvestigative Site US075Recruiting at this site
  • St. Petersburg, United StatesInvestigative Site US074Recruiting at this site
  • West Palm Beach, United StatesInvestigative Site US073Recruiting at this site
  • Atlanta, United StatesInvestigative Site US023Recruiting at this site
  • Evanston, United StatesInvestigative Site US030Recruiting at this site

In total, worldwide, 106 of the 228 sites listed in the registry are recruiting; the other 122 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 8, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 76 more locations

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.