NCT06460298

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: ProDa BioTech, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	ProAgio 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.
DRUG	ProAgio Dose Expansion	ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.

Timeline

• Start date: 2024-08-20
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2024-06-14
• Last updated: 2025-08-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study