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Anti-metabolites

ProAgio + Gemcitabine for Breast Cancer

Phase 1 & 2

Recruiting

Led By Kevin Kalinsky, M.D, M.S

Research Sponsored by ProDa BioTech, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have received at least two lines of prior systemic treatment for advanced disease

ECOG performance status ≤2

Must not have

Participants who have had prior treatment with gemcitabine in the metastatic setting

Platelet transfusion within 7 days prior to treatment start

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a drug called ProAgio, in combination with Gemcitabine, for patients with metastatic triple negative breast cancer.

Who is the study for?

This trial is for patients with metastatic triple negative breast cancer. Details about who can join are not fully provided, but typically participants must meet certain health standards and have no conflicting conditions.

What is being tested?

The study is testing the safety and effectiveness of ProAgio, a new anti-cancer drug targeting specific proteins on cancer cells, combined with Gemcitabine, a chemotherapy medication.

What are the potential side effects?

Specific side effects are not listed here; however, common ones for new cancer drugs like ProAgio may include nausea, fatigue, allergic reactions and potential harm to healthy cells. Gemcitabine often causes flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone at least two treatments for my advanced illness.

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I can take care of myself but might not be able to do heavy physical work.

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I am an adult with advanced breast cancer that is not driven by estrogen, progesterone, or HER2.

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My organs and bone marrow are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with gemcitabine for cancer that has spread.

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I have not had a platelet transfusion in the last 7 days.

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I have a chronic neurological disorder that affects my movement, vision, or causes seizures.

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I have not had major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 (Dose Escalation)

Part 2 (Dose Expansion)

Secondary study objectives

Clinical Benefit Rate

Estimate the mean change from baseline in tumor stromal collagen

Progression free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

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

Group II: Dose EscalationExperimental Treatment1 Intervention

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

0 / 8Eligibility criteria met