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

NCT06460298 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-08-12

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Georgia State University

    collaborator OTHER

  • ProDa BioTech, LLC

    lead INDUSTRY

Principal Investigators

  • Kevin Kalinsky, M.D, M.S · Emory University Winship Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2026-07-01
Completion
2026-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06460298 on ClinicalTrials.gov