RecruitingPhase 1Phase 2NCT05735080

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

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


Sponsor

Incyclix Bio

Enrollment

150 participants

Start Date

Mar 28, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called INX-315 (a CDK2 inhibitor) in people with certain advanced cancers. CDK2 is a protein that drives cell division in some tumours, and blocking it may slow or stop cancer growth. The study focuses on three cancer types: hormone receptor-positive breast cancer (after CDK4/6 inhibitor treatment), ovarian cancer with a CCNE-1 gene amplification, and other solid tumours with CCNE-1 amplification. **You may be eligible if...** - You have advanced breast cancer (ER+/HER2-) that progressed after CDK4/6 inhibitor therapy, OR - You have platinum-resistant ovarian cancer with CCNE-1 amplification, OR - You have another advanced solid tumour with confirmed CCNE-1 amplification that has progressed on standard treatment - You are in good overall health (ECOG 0 or 1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have previously received a CDK2 or CDK2/4/6 inhibitor - You have active brain metastases causing symptoms or requiring steroids - You have lung disease (interstitial lung disease, radiation pneumonitis) - You have a prolonged QT interval on your ECG or history of QT prolongation - You have HIV, active hepatitis, or uncontrolled infection - You are pregnant or breastfeeding - You have difficulty swallowing oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINX-315

Oral administration

DRUGFulvestrant

Fulvestrant will be combined with INX-315

DRUGAbemaciclib

Abemaciclib will be combined with INX-315


Locations(18)

Florida Cancer Specialists

Orlando, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Levine Cancer Institute (LCI)- Atrium Health

Charlotte, North Carolina, United States

Duke Cancer Center/ DUMC

Durham, North Carolina, United States

Gabrail Cancer Research Center

Canton, Ohio, United States

Next Oncology

Dallas, Texas, United States

UTSW Medical Center

Dallas, Texas, United States

Oncology Consultants

Houston, Texas, United States

Next Oncology

Houston, Texas, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, Australia

Peter MacCallum Cancer Center

Parkville, Victoria, Australia

Mater Hospital

South Brisbane, Australia

View Full Details on ClinicalTrials.gov

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NCT05735080


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