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

NCT05085548 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 0001942R42CA217482-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Determine Recommended Phase 2 Dose (RP2D)

  Following completion of the dose escalation cohort, all available data relating to the pharmacokinetics, pharmacodynamics, efficacy and safety of ProAgio will be reviewed by the study team including the Principle Investigator, clinical pharmacology collaborators and the sponsor. A single ideal dose will then be selected for further investigation in the dose escalation cohort. This ideal dose may or may not be the same as the MTD.

  3 Years

Secondary Outcomes (9)

• Safety and Tolerability of ProAgio

  3 Years

• Evaluate the Maximum Plasma Concentration of ProAgio

  3 Years

• Evaluate the area under the curve of ProAgio

  3 Years

• Evaluate the Serum half-life of ProAgio

  3 Years

• Evaluate the volume of distribution of ProAgio

  3 Years

Other Outcomes (14)

• Assess whether a host antibody response against ProAgio develops with repeated administration

  2 Years

• Assess biologic effect of ProAgio on apoptosis of tumor cells in tumor tissue

  2 Years

• Assess biologic effect of ProAgio on integrin αvβ3 expression in tumor tissue

  2 Years

Study Arms (3)

Dose Escalation

EXPERIMENTAL

Participants will receive ProAgio in escalating doses.

Drug: ProAgio Dose Levels (DL) 1,2,3; Drug: ProAgio Dose Levels (DL) 4,5,6; Drug: ProAgio Dose Levels 4a,5a,6a

Expansion Biopsy Arm

EXPERIMENTAL

Pre- and post-treatment tumor biopsy is optional for participants enrolled in the standard arm, but mandatory for participants enrolled in the biopsy arm.

Drug: ProAgio Dose Levels 4a,5a,6a

Standard Arm

EXPERIMENTAL

Participants will receive ProAgio at the RP2D and may elect to receive concurrent gemcitabine beginning with the start of Cycle 2.

Drug: ProAgio Dose Levels (DL) 4,5,6; Drug: ProAgio Dose Levels 4a,5a,6a

Interventions

ProAgio Dose Levels (DL) 1,2,3 DRUG

ProAgio is administered to study participants by intravenous injections once every 14 days.

Also known as: ACT50

Dose Escalation

ProAgio Dose Levels (DL) 4,5,6 DRUG

ProAgio is administered to study participants by intravenous injections once every 7 days.

Also known as: ACT50

Dose Escalation; Standard Arm

ProAgio Dose Levels 4a,5a,6a DRUG

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.

Also known as: ACT50, Gemcitibine

Dose Escalation; Expansion Biopsy Arm; Standard Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the Escalation Cohort:
• Histologic or cytologic diagnosis of a solid tumor malignancy for which no curative therapy exists.
• Individuals must have evaluable disease, either by clinical exam, biochemical markers (including but not limited to CA 19-9 serum tumor marker for pancreatobiliary cancer, or other appropriate tumor marker in other tumor types), and/or radiographic studies.
• Individuals must have received at least one prior systemic treatment for advanced disease.
• For the Expansion Cohort:
• Histologic or cytologic diagnosis of non-neuroendocrine pancreatic cancer. Individuals with mixed acinar-neuroendocrine histology are eligible.
• All Participants must have measurable disease, per RECIST 1.1.
• All individuals must have advanced or recurrent disease and have received at least one prior systemic treatment. Specifically:
• Individuals with metastatic, locally advanced/unresectable, or borderline resectable pancreatic cancer at diagnosis, must have received at least one prior systemic treatment and still be considered ineligible for potentially curative resection.
• Individuals who have undergone surgical resection and have tumor recurrence that is not amenable to local therapy, are eligible if:
• Tumor recurs within six months of the completion of adjuvant therapy, OR
• Further standard of care therapy is not a viable option due to prior resistance or intolerance, or a medical contraindication to both FOLFIRINOX (or NALIRIFOX) and gemcitabine-based chemotherapy
• Individuals in the Biopsy Arm of the expansion cohort must have disease amenable to safe biopsy and willingness to undergo the procedure.
• All individuals must be more than 14 days removed from most recent standard of care or experimental drug treatment for their tumor.
• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ProAgio in individuals \<18 years of age, children are excluded from this study.

You may not qualify if:

• Diagnosis of primary malignant CNS tumor.
• Individuals who are receiving any other investigational agents.
• Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including but not limited to significant pulmonary disease other than that related to the primary cancer, uncontrolled diabetes mellitus, unstable angina, significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease) and/or psychiatric illness/social situations within 12 weeks that would limit compliance with study requirements.
• Individuals with known diagnosis of a chronic neurologic disorders (such as multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled epilepsy) which causes motor disturbance, visual disturbance or seizure and could confound assessment of neurologic toxicity caused by the study drug.
• Pregnant or nursing individuals are excluded from this study because ProAgio is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ProAgio, breastfeeding should be discontinued if the mother is treated with ProAgio.
• Individuals with leptomeningeal disease or with CNS metastases that are untreated, have required steroid treatment within the last 4 weeks, or anti-convulsant therapy in the last 14 days. For dose escalation cohort only: Individuals with any known CNS metastases are excluded. Those with symptoms suggestive of possible CNS metastases (such as new headaches) must undergo brain MRI as part of screening.
• Individuals who have undergone a recent minor surgical procedure (within \<14 days) such as biliary stenting or major surgical procedure (within ≥ 28 days).
• Individuals who have undergone recent (within ≤ 14 days) external beam radiation therapy are excluded. Individuals who have undergone recent (within ≤ 28 days) treatment with radioactive therapeutics (such as Y90 or radio-immune conjugates) are ineligible.
• Individuals with uncontrolled bleeding episodes \<28 days prior to enrollment are excluded.
• Individuals with active or uncontrolled infections are excluded.
• Individuals with HIV and detectable viral load are excluded. Patents on appropriate highly active anti-retroviral therapy with undetectable viral load are eligible.
• Individuals with a history of Hepatitis B or C are excluded unless there is documented evidence of effective treatment and/or cure with undetectable viral load.
• Individuals with recent (within \< 28 days) thromboembolic disease including but not limited to acute coronary syndrome, stroke, or transient ischemic attack, recent deep vein thrombosis or pulmonary embolism.
• Individuals with thromboembolic disease including but not limited to acute coronary syndrome, stroke, or transient ischemic attack, recent deep vein thrombosis or pulmonary embolism who have continued symptoms, or who are not on stable doses of appropriate antiplatelet / anticoagulant regimens are excluded.

Sponsors & Collaborators

• ProDa BioTech, LLC: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Anish Thomas, MBBS, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study includes a dose escalation arm, followed by an expansion arm at the ideal dose for participants with non-neuroendocrine pancreatic cancer.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 20, 2021
• Study Start: October 29, 2021
• Primary Completion: April 24, 2025
• Study Completion: April 10, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)