RECRUITING

Study of INCB123667 in Subjects With Advanced Solid Tumors

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Conditions

Solid Tumorsadvanced solid tumorsmetastatic solid tumorsGynecological Tumors,GI Tumors,Breast Cancer,Tumor Agnosticcyclin E1 geneepithelial ovarian carcinomafallopian carcinomaprimary peritoneal carcinomaclear cell ovarian cancerendometrial adenocarcinomauterine carcinosarcomauterine papillary serous carcinomagastrointestinal tumorsgastric adenocarcinomasGEJ adenocarcinomasesophageal adenocarcinomas

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-07-05
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05238922

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 years or older at the time of the signing of the ICF.
  2. * Life expectancy greater than 12 weeks.
  3. * ECOG performance status score of 0 or 1.
  4. * Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.
  5. * Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy.
  6. * Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer
  7. * Disease Group 2: Endometrial/Uterine Cancer
  8. * Disease Group 3: Gastric, GEJ, and esophageal carcinomas
  9. * Disease Group 4: TNBC
  10. * Disease Group 5: HR+/HER2- breast cancer
  11. * Disease Group 6: Other tumor indications excluding bone cancers
  12. * TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer or participants with a different tumor.
  13. * TGB and TGD: Participants with HR+/HER2- breast cancer.
  14. * TGH and TGJ:
  15. * Participants with HR+/HER2- breast cancer.
  16. * Participants with any other advanced or metastatic solid tumor.
  17. * TGI and TGK:
  18. * TGL, TGM and TGN:
  19. * Measurable lesions by CT or MRI based on RECIST v1.1 criteria.
  1. * History of clinically significant or uncontrolled cardiac disease.
  2. * History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
  3. * Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
  4. * Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.
  5. * 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.
  6. * Specific laboratory values.
  7. * Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.
  8. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study drug.
  9. * Prior treatment with any CDK2 inhibitor.
  10. * 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.
  11. * Any major surgery within 28 days before the first dose of study drug.
  12. * Any prior radiation therapy within 28 days before the first dose of study drug.
  13. * 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.
  14. * Active HBV or HCV infection that requires treatment.
  15. * Known history of HIV.
  16. * Known hypersensitivity or severe reaction to any component of study treatment or formulation components.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Liz Croft, MD
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
City of Hope-Lennar Foundation Cancer Center
Irvine, California, 92618
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
Emory University
Atlanta, Georgia, 30322
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
New York Presbyterian/Weill Cornell
New York, New York, 10065
United States
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina, 28078
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15213
United States
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas, 76104
United States
Virginia Cancer Institute
Fairfax, Virginia, 22031
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Liz Croft, MD, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-05
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2022-07-05
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • advanced solid tumors
  • metastatic solid tumors
  • Gynecological Tumors,
  • GI Tumors,
  • Breast Cancer,
  • Tumor Agnostic
  • cyclin E1 gene
  • epithelial ovarian carcinoma
  • fallopian carcinoma
  • primary peritoneal carcinoma
  • clear cell ovarian cancer
  • endometrial adenocarcinoma
  • uterine carcinosarcoma
  • uterine papillary serous carcinoma
  • gastrointestinal tumors
  • gastric adenocarcinomas
  • GEJ adenocarcinomas
  • esophageal adenocarcinomas

Additional Relevant MeSH Terms

  • Solid Tumors