NCT05238922

Study of INCB123667 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 604 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	INCB0123667	25 mg tablets
DRUG	Palbociclib	Palbociclib will be administered at protocol defined dose.
DRUG	Bevacizumab	Bevacizumab will be administered at protocol defined dose.
DRUG	Olaparib	Olaparib will be administered at protocol defined dose.
DRUG	Paclitaxel	Paclitaxel will be administered at protocol defined dose.
DRUG	Ribociclib	Ribociclib will be administered at protocol defined dose.
DRUG	Fulvestrant	Fulvestrant will be administered at protocol defined dose.

Timeline

• Start date: 2022-07-05
• Primary completion: 2027-07-27
• Completion: 2027-08-31
• First posted: 2022-02-14
• Last updated: 2026-04-14

Locations

42 sites across 8 countries: United States, France, Italy, Japan, Netherlands, Puerto Rico, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study