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RECRUITING Phase 1

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

NCT05735080 · View on ClinicalTrials.gov ↗

Study 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. 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).

Interventions

  • DRUG Fulvestrant
  • DRUG Abemaciclib
  • DRUG INX-315

Study Locations (17)

Texas

  • Next Oncology — Dallas
  • UTSW Medical Center — Dallas
  • Oncology Consultants — Houston
  • Next Oncology — Houston

Georgia

  • Emory Winship Cancer Institute — Atlanta
  • Georgia Cancer Center at Augusta University — Augusta

North Carolina

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

Florida

  • Florida Cancer Specialists — Lake Mary

Indiana

  • Fort Wayne Medical Oncology and Hematology — Fort Wayne

Massachusetts

  • Dana-Farber Cancer Institute — Boston

Michigan

  • Karmanos Cancer Institute — Detroit

New York

  • Roswell Park Cancer Institute — Buffalo

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2023-03-28
Est. Completion 2026-06
Phase Phase 1

Sponsor

Incyclix Bio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05735080

The ClinicalTrials.gov registry entry for NCT05735080 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyclix Bio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 9 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Fulvestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05735080 reports 17 study locations spanning 12 distinct geographic areas — top geographies include Texas, Georgia, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05735080 about?

NCT05735080 is a clinical study titled "Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer". 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 i...

What is the current status of trial NCT05735080?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2023-03-28. Estimated completion is 2026-06.

What conditions does trial NCT05735080 study?

This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Solid Tumor, Advanced Cancer, Metastatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05735080?

The interventions under investigation include: Fulvestrant (DRUG), Abemaciclib (DRUG), INX-315 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05735080?

This trial is sponsored by Incyclix Bio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05735080 being conducted?

This trial has 17 study locations across Florida, Georgia, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial