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Clinical Trial ● Currently Recruiting Phase I NCT05238922

Study of INCB123667 in Subjects With Advanced Solid Tumors

Study of INCB123667 in Subjects With Advanced Solid Tumors — Recruiting • Phase I • Oncology • NCT05238922.

📅 14 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT05238922
Sponsor
Incyte Corporation
Start
2022-07-05
ClinicaliQ Trial Snapshot
  • Study of INCB123667 in Subjects With Advanced Solid Tumors — Recruiting • Phase I • Oncology • NCT05238922.
  • Drug Being Tested: INCB123667 is a novel investigational agent being evaluated for safety, tolerability, pharmacokinetics, and anti-tumour efficacy in advanced/metastatic solid tumours, tested both as monotherapy and in combination with established anticancer therapies.
  • Patient Eligibility Overview: The trial enrolls adults with advanced or metastatic solid tumours; specific eligibility criteria determine which tumour types and patient populations receive monotherapy versus combination treatment arms.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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…

Eligibility Snapshot
  • : * Adults aged 18 years or older at the time of the signing of the ICF. * Life expectancy greater than 12 weeks. * ECOG performance status score of 0 or 1. * Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome. * Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy. For Part 1: Participants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors. Participants in Part 1B (dose expansion): * Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer * Disease Group 2: Endometrial/Uterine Cancer * Disease Group 3: Gastric, GEJ, and esophageal carcinomas * Disease Group 4: TNBC * Disease Group 5: HR+/HER2- breast cancer * Disease Group 6: Other tumor indications excluding bone cancers For Part 2: Participants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors. * TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer or participants with a different tumor. * TGB and TGD: Participants with HR+/HER2- breast cancer. Participants in Part 2b (dose expansion): * TGH and TGJ: *…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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