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

ClinicalTrials.gov ID: NCT05735080

Public ClinicalTrials.gov record NCT05735080. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT05735080
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Incyclix Bio; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 27, 2023
Primary completion: Jun 30, 2027
Completion: Aug 31, 2027
Last update posted: Mar 31, 2026

2023 – 2027

United States locations

U.S. sites: 15
U.S. states: 10
U.S. cities: 13

Facility	City	State	ZIP	Site status
Florida Cancer Specialists	Orlando	Florida	32827	Recruiting
Emory Winship Cancer Institute	Atlanta	Georgia	30322	Recruiting
Georgia Cancer Center at Augusta University	Augusta	Georgia	30912	Recruiting
Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	46804	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	48201	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	14263	Recruiting
Levine Cancer Institute (LCI)- Atrium Health	Charlotte	North Carolina	28204	Recruiting
Duke Cancer Center/ DUMC	Durham	North Carolina	27705	Recruiting
Gabrail Cancer Research Center	Canton	Ohio	44718	Recruiting
Next Oncology	Dallas	Texas	75039	Recruiting
UTSW Medical Center	Dallas	Texas	75390	Recruiting
Oncology Consultants	Houston	Texas	77030	Not yet recruiting
Next Oncology	Houston	Texas	77054	Recruiting
Northwest Medical Specialties, PLLC	Tacoma	Washington	98405	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05735080, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 31, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05735080 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →