NCT05085548

ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies

A Phase I Trial of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, for Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: ProDa BioTech, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Advanced Pancreatic Cancer
• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	ProAgio Dose Levels (DL) 1,2,3	ProAgio is administered to study participants by intravenous injections once every 14 days.
DRUG	ProAgio Dose Levels (DL) 4,5,6	ProAgio is administered to study participants by intravenous injections once every 7 days.
DRUG	ProAgio Dose Levels 4a,5a,6a	ProAgio is administered to study participants by intravenous injections once every 7 days with a drug holiday after every 5 administrations. Optional co-administration of gemcitabine (Gem) during dose expansion beginning with Cycle 2.

Timeline

• Start date: 2021-10-29
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2021-10-20
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study