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About
The study is a first-in-human, Phase I study to assess the safety of ProAgio in participants with advanced solid tumor malignancies including pancreatic cancer.
Full description
Pancreatic cancer is the third leading cause of death from cancer in the United States. The median overall survival for patients with metastatic disease who are receiving the most effective combination of chemotherapy regimens remains less than 1 year.
ProAgio has been evaluated in nonclinical pharmacology, safety pharmacology, pharmacokinetic (PK), and toxicity studies. It has demonstrated efficacy at treating pancreatic cancer and prolonging survival in mice.
ProAgio is being developed for intravenous (IV) administration. All participants will receive ProAgio until disease progression, unacceptable toxicity, or withdrawal from study. Subjects in the dose escalation cohorts who will be administered ProAgio at doses ranging from 3.2 to 36.8 mg/kg.
Following the dose escalation phase, an expansion cohort of patients with advanced nonendocrine pancreatic adenocarcinoma will be administered ProAgio at the maximum tolerated dose (MTD) from the dose escalation phase. Patients will also be offered optional co-administration of gemcitabine (Gem). The expansion cohort will contain two arms: A) Biopsy Arm (8 participants), and B) Standard Arm (8 participants). Tumor biopsies performed pre- and post- (on Cycle 2 Day 2-3) ProAgio treatment are optional for participants enrolled in the Standard Arm, but mandatory for participants enrolled in the Biopsy Arm.
Enrollment
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Volunteers
Inclusion criteria
Histologically or cytologically confirmed diagnosis of a solid tumor malignancy for which no curative therapy exists as confirmed by the NCI Laboratory of Pathology.
For expansion cohort: histologically or cytologically confirmed diagnosis of nonneuroendocrine pancreatic cancer. Participants with mixed acinar- neuroendocrine histology are permitted.
Participants in the Biopsy Arm of the expansion cohort must have disease amenable to safe biopsy and willingness to undergo the procedure.
Participants must have received at least one prior systemic treatment for advanced disease. Participants must be more than 14 days removed from most recent standard of care or experimental drug treatment for their tumor
Participants in the dose escalation cohort must have evaluable disease, either by clinical exam, biochemical markers (including but not limited to CA 19-9 serum tumor marker for pancreatobiliary cancer participants, or other appropriate tumor marker in other tumor types), and/or radiographic studies.
Participants in the expansion cohort must have measurable disease, per RECIST 1.1.
Age >18 years. Because no dosing or adverse event data are currently available on the use of ProAgio in participants <18 years of age, children are excluded from this study.
ECOG performance status <2 (Karnofsky >60%.
Participants must have adequate organ and marrow function as defined below:
OR
Participants must have:
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 3 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.
Ability of subject to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
58 participants in 3 patient groups
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Central trial contact
Zhi-Ren Liu; Damon R Michaels
Data sourced from clinicaltrials.gov
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