Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
ProDa BioTech, LLC
Summary
This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer
Description
This is a single-arm, Phase I/II study, designed to evaluate the safety and efficacy of the combination of ProAgio with gemcitabine in patients with previously treated, metastatic triple negative breast cancer. Dose escalation will proceed using the Bayesian Optimal Interval (BOIN) design, with a target toxicity rate of 0.25, a maximum sample size of 20, and a cohort size of 2. There are four dose levels considered in the dose escalation phase, and we start at the lowest dose level (Dose Level 1).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult participants, ≥ 18 years of age, with histologically or cytologically confirmed metastatic breast cancer that is estrogen receptor (ER) negative (less than 10%), progesterone receptor (PR) negative (less than 10%), and HER2 negative/unamplified as per ASCO/CAP guidelines (Wolff et al., 2018). If ER/PR less than 10%, prior endocrine therapy is permitted, and the participant is not considered appropriate for hormone based therapy. Participants must agree to provide archival tumor material from metastatic site (most recent archival tumor tissue immediately prior to en…
Interventions
- DrugProAgio Dose Levels (DL) 1,2,3,4
ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
- DrugProAgio Dose Expansion
ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
Locations (2)
- Emory University Winship Cancer InstituteAtlanta, Georgia
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia