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

NCT05085548 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Advanced Pancreatic Cancer
  • Solid Tumor Malignancies

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • ProDa BioTech, LLC

    lead INDUSTRY

Principal Investigators

  • Anish Thomas, MBBS, MD · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2025-04-24
Completion
2026-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085548 on ClinicalTrials.gov