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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
ProDa BioTech, LLC
Study ID
NCT06460298
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ProAgio Dose Levels (DL) 1,2,3,4 — DRUG
    ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
  • ProAgio Dose Expansion — DRUG
    ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.

Study Details

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

Key Dates

Start date
Aug 20, 2024
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Experimental: Dose Escalation ProAgio Dose Levels (DL) 1,2,3,4 ProAgio combined with Gemcitabine is administered to study participants by intravenous injections on days 1, 8, 15, every 4-week Cycle. Other Names: ACT50, and Gemcitabine
  • Experimental: Dose Expansion
    Participants will receive ProAgio at the objective response rate (ORR) combined with Gemcitabine is administered to study participants by intravenous injections on days 1, 8, 15 every 4-week Cycle. Other Names: ACT50, and Gemcitabine

Primary Outcome Measure

Part 1 (Dose Escalation) [ Time Frame: 2 Years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Ashley Trumbull
[email protected]
404-778-3969
Kathleen Coleman
[email protected]

Find similar trials in Atlanta, GA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Emory University Winship Cancer Institute· Atlanta, GAWinship Cancer Institute of Emory University· Atlanta, GA

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