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NCT05735080 · ClinicalTrials.gov registry record · Phase 1
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Incyclix Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 17
- Study locations
NCT05735080 is a Phase 1 study of Breast Cancer and Ovarian Cancer that is actively recruiting participants, run by Incyclix Bio. The registered enrollment target is 150 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 17 study locations across 12 states.
The verdict
NCT05735080, a Phase 1 study of Breast Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by Incyclix Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 17
- Study locations
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Incyclix Bio, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT05735080 reports 17 study locations spanning 12 distinct geographic areas - top geographies include Texas, Georgia, North Carolina.
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.
What interventions are being tested in trial NCT05735080?
The interventions under investigation include: Fulvestrant (DRUG), Abemaciclib (DRUG), INX-315 (DRUG).
Who is sponsoring clinical trial NCT05735080?
This trial is sponsored by Incyclix Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.