Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer (NCT05735080)
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer
🩺 Plain-English Summary (8th-Grade Level)
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. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \[a CDK4/6i\] and fulvestrant \[a SERD\] in advanced/metastatic breast cancer; dose escalation and expansion).
Who can join: Review the eligibility criteria below.
Location: Florida Cancer Specialists — Orlando, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- Florida Cancer Specialists — Orlando, Florida
- Emory Winship Cancer Institute — Atlanta, Georgia
- Georgia Cancer Center at Augusta University — Augusta, Georgia
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Roswell Park Cancer Institute — Buffalo, New York
- Levine Cancer Institute (LCI)- Atrium Health — Charlotte, North Carolina
- Duke Cancer Center/ DUMC — Durham, North Carolina
- Gabrail Cancer Research Center — Canton, Ohio
- Next Oncology — Dallas, Texas
- UTSW Medical Center — Dallas, Texas
- Oncology Consultants — Houston, Texas
- Next Oncology — Houston, Texas
- Northwest Medical Specialties, PLLC — Tacoma, Washington
- Peninsula and South Eastern Haematology & Oncology Group — Frankston, Victoria
- Peter MacCallum Cancer Center — Parkville, Victoria
- Mater Hospital — South Brisbane,
📞 Contact the Study Coordinator
Phone: (919) 328-0003
Email: clinicalinfo@incyclixbio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.