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Study of INCB123667 in Subjects With Advanced Solid Tumors

NCT05238922 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Liz Croft, MD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2027-07-27
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Japan
  • Netherlands
  • Puerto Rico
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238922 on ClinicalTrials.gov