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Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

NCT05735080

This study is recruiting at 14 US sites in 10 states, according to its ClinicalTrials.gov record last updated .

Summary

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Breast Cancer
  • Breast Cancer Metastatic
  • Hormone Receptor Positive Tumor
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Ovarian Cancer
  • CCNE1 Amplification
  • Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Incyclix Bio
Last updated on ClinicalTrials.gov
April 1, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • Florida Cancer Specialists · Orlando, FL

Georgia · 2

  • Emory Winship Cancer Institute · Atlanta, GA
  • Georgia Cancer Center at Augusta University · Augusta, GA

Indiana · 1

  • Fort Wayne Medical Oncology and Hematology · Fort Wayne, IN

Massachusetts · 1

  • Dana-Farber Cancer Institute · Boston, MA

Michigan · 1

  • Karmanos Cancer Institute · Detroit, MI

New York · 1

  • Roswell Park Cancer Institute · Buffalo, NY

North Carolina · 2

  • Levine Cancer Institute (LCI)- Atrium Health · Charlotte, NC
  • Duke Cancer Center/ DUMC · Durham, NC

Ohio · 1

  • Gabrail Cancer Research Center · Canton, OH

Texas · 3

  • Next Oncology · Dallas, TX
  • UTSW Medical Center · Dallas, TX
  • Next Oncology · Houston, TX

Washington · 1

  • Northwest Medical Specialties, PLLC · Tacoma, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.