Triple Negative Breast CancerPhase 1/2NCT06460298
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
A Phase 1/2 study testing ProAgio Dose Levels (DL) 1,2,3,4 and ProAgio Dose Expansion in people with Triple Negative Breast Cancer, run by ProDa BioTech, LLC at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- ProAgio Dose Levels (DL) 1,2,3,4 and ProAgio Dose Expansion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Aug 2024to 1 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants, ≥ 18 years of age, with histologically or cytologically confirmed metastatic breast cancer that is estrogen receptor (ER) negative (less than 10%), progesterone receptor (PR) negative (less than 10%), and HER2 negative/unamplified as per ASCO/CAP guidelines (Wolff et al., 2018). If ER/PR less than 10%, prior endocrine therapy is permitted, and the participant is not considered appropriate for hormone based therapy. Participants must agree to provide archival tumor material from metastatic site (most recent archival tumor tissue immediately prior to enrollment is strongly preferred) and must agree to undergo research tumor biopsy before treatment and during cycle 2 at the same site of metastatic disease, if presence of easily accessible lesion, at the discretion of the treating physician.
- Participants must have received at least two lines of prior systemic treatment for advanced disease. If participants received systemic therapy in the operable setting and the tumor progressed within 12 months of the receipt of the last dose of systemic therapy, this will be considered one line of prior systemic therapy for advance disease. Participants must be more than 14 days removed from most recent standard of care or experimental drug treatment for their tumor.
- ECOG performance status ≤2
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
- Hemoglobin ≥9 g/ dL (recent transfusion allowed)
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- Platelets ≥100,000/mcL
- AST(SGOT)/ALT(SGPT) ≤3 x ULN. AST and ALT (up to 5x ULN is permitted for participants with liver metastases)
- Total bilirubin ≤1.5 x institutional ULN
- Creatinine clearance ≥60 mL/min (measured using Cockcroft- Gault equation or the estimated glomerular filtration rate)
- Participants with CNS metastases must be treated and/or stable (no progression for at least 4 weeks after local prior therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period). Those with symptoms suggestive of possible CNS metastases (such as new headaches) must undergo brain MRI as part of screening.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The effects of ProAgio on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for the 6 months following the last dosing of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- During dose escalation, participants with bone only and/or non-measurable disease are eligible. During dose expansion, only participants with measurable disease are eligible.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had prior treatment with gemcitabine in the metastatic setting.
- Platelet transfusion within 7 days prior to treatment start.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with history of known congestive heart failure (left ventricular ejection fraction (LVEF) <50%) must have documented LVEF >50% within 12 months of study enrollment.
- Prolonged QTc interval >480 msec on screening EKG
- Participants with known diagnosis of a chronic neurologic disorders (such as multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled epilepsy) which causes motor disturbance, visual disturbance, or seizure and could confound assessment of neurologic toxicity caused by the study drug.
- Pregnant or nursing women are excluded from this study because ProAgio is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ProAgio, breastfeeding should be discontinued if the mother is treated with ProAgio.
- Participants who have undergone a major surgical procedure (within < 28 days) are excluded.
- Participants with uncontrolled bleeding episodes <28 days prior to enrollment are excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zhi-Ren Liu contact
United States2 sites, 2 recruiting
- Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
- Not yet recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Ashley Trumbull, 404-778-3969, ashley.lynn.trumbull@emory.edu
Kathleen Coleman, kathleen.marie.coleman@emory.edu
About this study
Official title: 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
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
Read the 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
- Being tested
- ProAgio Dose Levels (DL) 1,2,3,4, ProAgio Dose Expansion
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProAgio Dose Levels (DL) 1,2,3,4Drug
Also called ACT50, Gemcitabine
ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
ProAgio Dose ExpansionDrug
Also called ACT50, Gemcitabine
ProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 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 Receives: Drug: ProAgio Dose Levels (DL) 1,2,3,4 |
| Dose Expansion | Experimental | 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 Receives: Drug: ProAgio Dose Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (Dose Escalation)
To identify the maximum tolerated dose (MTD) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
Measured: 2 Years
Part 2 (Dose Expansion)
To estimate the objective response rate (ORR) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
Measured: 2 Years
Secondary outcomes (3)
Clinical Benefit Rate
To describe the clinical benefit rate (CBR) in patients with metastatic TNBC treated with ProAgio in combination with gemcitabine.
Measured: 2 Years
Estimate the mean change from baseline in tumor stromal collagen
To estimate the mean change from baseline in tumor stromal collagen following treatment with ProAgio and gemcitabine.
Measured: 2 Years
Progression free survival (PFS)
To describe the progression free survival (PFS) in patients with metastatic TNBC treated with ProAgio in combination with gemcitabine.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 Aug 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study includes a dose escalation arm, followed by an expansion arm at the ideal dose for participants To estimate the objective response rate (ORR) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProDa BioTech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University, Georgia State University
- Responsible party
- Sponsor
- Investigators
- Kevin Kalinsky, M.D, M.S, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460298
- Sponsor's protocol ID
- BIO 01192022
- Status last verified
- Aug 2025
- First submitted
- 10 Jun 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06460298
- Acronym / sponsor ID
- BIO 01192022
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- ProDa BioTech, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Emory University, Georgia State University
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study includes a dose escalation arm, followed by an expansion arm at the ideal dose for participants To estimate the objective response rate (ORR) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ProAgio Dose Levels (DL) 1,2,3,4Experimental: 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 |
| Dose Expansion | Experimental | Drug: ProAgio Dose ExpansionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult participants, ≥ 18 years of age, with histologically or cytologically confirmed metastatic breast cancer that is estrogen receptor (ER) negative (less than 10%), progesterone receptor (PR) negative (less than 10%), and HER2 negative/unamplified as per ASCO/CAP guidelines (Wolff et al., 2018). If ER/PR less than 10%, prior endocrine therapy is permitted, and the participant is not considered appropriate for hormone based therapy. Participants must agree to provide archival tumor material from metastatic site (most recent archival tumor tissue immediately prior to enrollment is strongly preferred) and must agree to undergo research tumor biopsy before treatment and during cycle 2 at the same site of metastatic disease, if presence of easily accessible lesion, at the discretion of the treating physician.
- Participants must have received at least two lines of prior systemic treatment for advanced disease. If participants received systemic therapy in the operable setting and the tumor progressed within 12 months of the receipt of the last dose of systemic therapy, this will be considered one line of prior systemic therapy for advance disease. Participants must be more than 14 days removed from most recent standard of care or experimental drug treatment for their tumor.
- ECOG performance status ≤2
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
Key exclusion criteria (8 listed)
- Participants who have had prior treatment with gemcitabine in the metastatic setting.
- Platelet transfusion within 7 days prior to treatment start.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with history of known congestive heart failure (left ventricular ejection fraction (LVEF) <50%) must have documented LVEF >50% within 12 months of study enrollment.
- Prolonged QTc interval >480 msec on screening EKG
- Participants with known diagnosis of a chronic neurologic disorders (such as multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled epilepsy) which causes motor disturbance, visual disturbance, or seizure and could confound assessment of neurologic toxicity caused by the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProAgio Dose Levels (DL) 1,2,3,4Also: ACT50, GemcitabineProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy. | Drug | Dose Escalation |
| ProAgio Dose ExpansionAlso: ACT50, GemcitabineProAgio combined with Gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy. | Drug | Dose Expansion |
Primary outcome
Part 1 (Dose Escalation)
Time frame: 2 Years
To identify the maximum tolerated dose (MTD) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
Part 2 (Dose Expansion)
Time frame: 2 Years
To estimate the objective response rate (ORR) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
3 secondary outcomes
Clinical Benefit Rate
Time frame: 2 Years
Estimate the mean change from baseline in tumor stromal collagen
Time frame: 2 Years
Progression free survival (PFS)
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhi-Ren Liu contact
Kevin Kalinsky, M.D, M.S principal investigator
Emory University Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ProAgio Dose Levels (DL) 1,2,3,4 and ProAgio Dose Expansion in people with Triple Negative Breast Cancer, run by ProDa BioTech, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damon Michaels (615-614-1185, damon.michaels@medelis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 (Dose Escalation) (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.