NCT06179160

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	INCB161734	INCB161734 will be administered at protocol defined dose.
DRUG	Cetuximab	Cetuximab will be administered at protocol defined dose.
DRUG	Retifanlimab	Retifanlimab will be administered at protocol defined dose.
DRUG	GEMNabP	GEMNabP will be administered at protocol defined dose.
DRUG	mFOLFIRINOX	mFOLFIRINOX will be administered at protocol defined dose.
DRUG	FOLFOX	FOLFOX will be administered at protocol defined dose.
DRUG	FOLFIRI	FOLFIRI will be administered at protocol defined dose.
DRUG	INCA33890	INCA33890 will be administered at protocol defined dose.

Timeline

• Start date: 2024-01-04
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-12-21
• Last updated: 2026-03-16

Locations

34 sites across 8 countries: United States, Australia, Belgium, Canada, France, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study