ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06460298
Trial Phases:	Phase I Phase II	Protocol IDs:	BIO 01192022 (primary) NCI-2024-07988
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	ProDa BioTech, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT06460298

Summary

This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- avß3
Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple
Negative Breast Cancer

Objectives

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).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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