Study of INCB123667 in Subjects With Advanced Solid Tumors

Description

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

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Study Overview

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Study Details

Study overview

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).

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

Study of INCB123667 in Subjects With Advanced Solid Tumors

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Irvine

City of Hope-Lennar Foundation Cancer Center, Irvine, California, United States, 92618

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Lone Tree

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States, 80124

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06510

Miami Beach

Mount Sinai Medical Center Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

New York

New York Presbyterian/Weill Cornell, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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
  • * 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.
  • * TGH and TGJ:
  • * Participants with HR+/HER2- breast cancer.
  • * Participants with any other advanced or metastatic solid tumor.
  • * TGI and TGK:
  • * TGL, TGM and TGN:
  • * Measurable lesions by CT or MRI based on RECIST v1.1 criteria.
  • * History of clinically significant or uncontrolled cardiac disease.
  • * History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
  • * Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
  • * Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.
  • * Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.
  • * Specific laboratory values.
  • * Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.
  • * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study drug.
  • * Prior treatment with any CDK2 inhibitor.
  • * Any change in endocrine therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug or any administration of targeted therapy, antibody, or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
  • * Any major surgery within 28 days before the first dose of study drug.
  • * Any prior radiation therapy within 28 days before the first dose of study drug.
  • * Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
  • * Active HBV or HCV infection that requires treatment.
  • * Known history of HIV.
  • * Known hypersensitivity or severe reaction to any component of study treatment or formulation components.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Liz Croft, MD, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2026-07-30