INX-315-01: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients with Advanced Cancer
INX-315-01: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients with Advanced Cancer
To determine the safety and tolerability of INX-315 monotherapy and in
combination with fulvestrant in adult patients with HR+/HER2- advanced or metastatic breast cancer.
Inclusion Criteria
At least 18 years of age
One of the following advanced cancer types
HR+/HER2- Breast Cancer
Ovarian/ fallopian/ primary peritoneal cancer
Confirmed diagnosis of advanced or metastic solid tumor that has progressed after prior standard therapy
ECOG score of 0 or 1
Not pregnant, agrees to contraceptive use
Exclusion Criteria
Rapid disease progression
Previous treatment with a CDK2/4/6 inhibitor
Clinically significant heart, lung, bleeding, or central nervous system conditions.
HIV, Hepatitis, or other uncontrolled infective Diagnosis