ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
BIO 01192022 (primary)
NCI-2024-07988
Summary
This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- avß3
Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple
Negative Breast Cancer
Objectives
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).
Eligibility
- 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)
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.