drugset / Trial / NCT05238922

Study of INCB123667 in Subjects With Advanced Solid Tumors

NCT05238922

Phase 1 Recruiting 604 enrolled Incyte Corporation
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2022-07-05
Primary completion
2027-07-27
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody
Subject Fulvestrant Small molecule
Subject INCB0123667 Unknown 25 mg Oral
Subject Olaparib Small molecule
Subject Paclitaxel Small molecule
Subject Palbociclib Small molecule
Subject Ribociclib Small molecule

Indications