Investigational Drug
ProAgio
TrialFetch AI Analysis
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Overview
ProAgio (ACT-50) is an investigational, intravenously administered drug being studied for cancer. The reported human results come from a small, first-in-human phase I study in previously treated advanced cancers, predominantly pancreatic cancer. They are too preliminary to establish clinical benefit. (clinicalstudies.info.nih.gov)
Mechanism of action
ProAgio targets integrin αvβ3, found on some cancer-associated fibroblasts and blood-vessel cells. Laboratory studies indicate that it binds outside the integrin’s usual ligand-binding site and triggers cell death through caspase-8 activation. Studies in pancreatic-cancer models suggest that targeting these cells may alter the tumor environment and improve chemotherapy delivery; those effects have not been established as clinical benefits. (pmc.ncbi.nlm.nih.gov)
Efficacy
As of the January 30, 2024 cutoff reported in a conference abstract, 28 people had received ProAgio alone, including 26 with pancreatic cancer. Five participants with pancreatic cancer receiving weekly treatment had stable disease; two also had stabilization of the CA 19-9 tumor marker. The abstract did not report any complete or partial responses or an overall response rate. Stable disease is not the same as tumor shrinkage. (ascopubs.org)
Safety
The same abstract reported that most treatment-related adverse events were transient and grade 1 or 2. Two participants had grade 2 infusion reactions and continued treatment after increased premedication. Three separate participants had grade 3 serious adverse events—hyperglycemia, acute kidney injury, or anemia—considered at least possibly related to ProAgio. Longer-term safety remains uncertain. (ascopubs.org)
Further reading
Last updated: Sep 2026
Active trials using ProAgio
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with measurable advanced or metastatic colorectal adenocarcinoma and ECOG 0–1 receive investigational ProAgio, an integrin αvβ3–targeting cytotoxin, with FOLFIRI and bevacizumab. Prior FOLFOX for metastatic disease is allowed during dose escalation, but expansion patients cannot have received 5-FU–based therapy for metastatic disease; prior FOLFIRI is excluded.
ClinicalTrials.gov ID: NCT06867822
TrialFetch AI summary: Adults with metastatic triple-negative breast cancer after at least two prior systemic treatment lines for advanced disease, and no prior gemcitabine for metastatic disease, receive intravenous ProAgio plus gemcitabine. ProAgio is an investigational cytotoxin targeting integrin αvβ3 on tumor-associated fibroblasts and vascular cells.
ClinicalTrials.gov ID: NCT06460298
TrialFetch AI summary: Adults with stage IV pancreatic adenocarcinoma, ECOG 0–1, measurable disease, and a safely biopsiable lesion receive investigational ProAgio, an integrin αvβ3-targeting cytotoxin, with gemcitabine and nab-paclitaxel during dose escalation. Expansion cohorts evaluate ProAgio alone or with the chemotherapy combination in patients previously treated with 5-FU–based therapy.
ClinicalTrials.gov ID: NCT06182072
