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

Recruiting Phase 1 Phase 2 Interventional Study
Breast Cancer Breast Cancer Metastatic Hormone Receptor Positive Tumor Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Ovarian Cancer CCNE1 Amplification Solid Tumor Advanced Cancer Metastatic Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Incyclix Bio · Industry
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About This Trial
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+)/Huma…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Advanced unresectable or metastatic HR+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor in the adjuvant or advanced/metastatic setting. 2. Advanced/ metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fall…
Contacts

Clinical Director

1-919-328-0003

clinicalinfo@incyclixbio.com

CONTACT