A Modular, Multipart, Multiarm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies
This modular, Phase I/IIa study aims to investigate the optimal dose of CT7001 when used alone or in combination with other anti-cancer treatments.
Advanced Solid Malignancies
Module 2 Part A, B and C: Locally advanced or metastatic hormone-receptor (HR) positive and human epidermal growth factor-2 (HER2) negative breast cancer
Female 18 years and older
Metastatic or locally advanced hormone receptor positive, HER2-negative breast cancer
Ability to swallow oral medication
Must have received an aromatase inhibitor with a CDK4/6 inhibitor for locally advanced or metastatic disease, or for treatment of early breast cancer if the disease-free interval was more than 12 months
Must NOT have prior therapy with fulvestrant
Must NOT have had more than 2 lines of endocrine treatment for locally advanced or metastatic disease
18 - 101
Healthy Volunteers Needed
Duration of Participation
You will receive the study drugs for as long as your cancer does not get worse, or you do not have bad side effects. If you stop the study drugs for reasons other than worsening of your disease, you will continue to have tumor assessments (scans) performed every 8 weeks for the first year, and then every 12 weeks in the following years until your disease worsens or you start new cancer treatment.
Knight Cancer Institute Clinical Trials