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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

Phase
Phase 1
Sponsor
Incyte Corporation
Enrollment
604
Timeline
Jul 2022 → Aug 2027
About This Study

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).

Eligibility Criteria

Inclusion Criteria

  • 1Adults aged 18 years or older at the time of the signing of the ICF.
  • 2Life expectancy greater than 12 weeks.
  • 3ECOG performance status score of 0 or 1.
  • 4Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.
  • 5Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy.
  • 6For Part 1:
  • 7Participants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
  • 8Participants in Part 1B (dose expansion):
  • 9Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer
  • 10Disease Group 2: Endometrial/Uterine Cancer
  • 11Disease Group 3: Gastric, GEJ, and esophageal carcinomas
  • 12Disease Group 4: TNBC
  • 13Disease Group 5: HR+/HER2- breast cancer
  • 14Disease Group 6: Other tumor indications excluding bone cancers
  • 15For Part 2:
  • 16Participants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
  • 17TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer or participants with a different tumor.
  • 18TGB and TGD: Participants with HR+/HER2- breast cancer.
  • 19Participants in Part 2b (dose expansion):
  • 20TGH and TGJ:
  • 21Participants with HR+/HER2- breast cancer.
  • 22Participants with any other advanced or metastatic solid tumor.
  • 23TGI and TGK:
  • 24Participants with HR+/HER2- breast cancer.
  • 25TGL, TGM and TGN:
  • 26Participants with advanced or metastatic epithelial ovarian/fallopian/primary peritoneal carcinoma.
  • 27Measurable lesions by CT or MRI based on RECIST v1.1 criteria.

Exclusion Criteria

  • 1History of clinically significant or uncontrolled cardiac disease.
  • 2History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
  • 3Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
  • 4Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.
  • 5Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.
  • 6Specific laboratory values.
  • 7Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.
  • 8Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study drug.
  • 9Prior treatment with any CDK2 inhibitor.
  • 10Any 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.
  • 11Any major surgery within 28 days before the first dose of study drug.
  • 12Any prior radiation therapy within 28 days before the first dose of study drug.
  • 13Undergoing 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.
  • 14Active HBV or HCV infection that requires treatment.
  • 15Known history of HIV.
  • 16Known hypersensitivity or severe reaction to any component of study treatment or formulation components.

Locations

46 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

City of Hope Medical Center

Duarte, California 91010

Recruiting

City of Hope-Lennar Foundation Cancer Center

Irvine, California 92618

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →