Advanced Pancreatic CancerPhase 1NCT05085548
ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies
A Phase 1 study testing ProAgio Dose Levels (DL) 1,2,3, ProAgio Dose Levels (DL) 4,5,6 and ProAgio Dose Levels 4a,5a,6a in people with Advanced Pancreatic Cancer and Solid Tumor Malignancies, run by ProDa BioTech, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer, Solid Tumor Malignancies
- What is being tested?
- ProAgio Dose Levels (DL) 1,2,3, ProAgio Dose Levels (DL) 4,5,6 and ProAgio Dose Levels 4a,5a,6a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2021to 10 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- ECOG performance status ≤ 2 (Karnofsky ≥>60%).
- Individuals must have adequate organ and marrow function as defined below:
- Aabsolute neutrophil count (ANC) ≥1,000/mcL
- hemoglobinHemoglobin (hgb) ≥9 g/ dL
- plateletsPlatelets ≥75,000/mcL
- Aspartate aminotransferase (AST)/ alanine transaminase (ALT) ( ≤ 2.5 x institutional upper limit of normal (ULN). AST and ALT (up to 5x ULN) is permitted for participants individuals with liver metastases)
- Total bilirubin ≤1.5 X institutional ULN
- Creatinine within normal institutional limits OR
- creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
- Serum albumin >2.5 mg/dL without intravenous supplementation
- Individuals must also have:
- Baseline QTcF interval of ≤ 470 ms
- Baseline resting heart rate > 45 beats per minute and <100 beats per minute
- Individuals of child-bearing potential (IOCBP) and individuals able to father a child men must agree to use an effective method of contraception as follows:
- IOCBP must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after the last dose of study drug(s).
- Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask them to be on an effective birth control (hormonal, intrauterine device [(IUD)], surgical sterilization.
- Ability of individual to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, for Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies
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.
Read the 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.
- Being tested
- ProAgio Dose Levels (DL) 1,2,3, ProAgio Dose Levels (DL) 4,5,6, ProAgio Dose Levels 4a,5a,6a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProAgio Dose Levels (DL) 1,2,3Drug
Also called ACT50
ProAgio is administered to study participants by intravenous injections once every 14 days.
ProAgio Dose Levels (DL) 4,5,6Drug
Also called ACT50
ProAgio is administered to study participants by intravenous injections once every 7 days.
ProAgio Dose Levels 4a,5a,6aDrug
Also called ACT50, Gemcitibine
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants will receive ProAgio in escalating doses. Receives: 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. Receives: 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. Receives: Drug: ProAgio Dose Levels (DL) 4,5,6; Drug: ProAgio Dose Levels 4a,5a,6a |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Years
Secondary outcomes (9)
Safety and Tolerability of ProAgio
Toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced. This will take place during the dose escalation phase as well as during the expansion phase.
Measured: 3 Years
Evaluate the Maximum Plasma Concentration of ProAgio
ProAgio concentrations will be measured by a validated ELISA assay modified from the assay used in non-clinical studies. This PK data will be used to mathematically describe the kinetic disposition of ProAgio in humans following the current dosing schedule.
Measured: 3 Years
Evaluate the area under the curve of ProAgio
Statistical analysis of study data will calculate the area under the plasma concentration curve for each study subject that received ProAgio.
Measured: 3 Years
Evaluate the Serum half-life of ProAgio
ProAgio Serum half-life will be determined using standard statistical calculations. .
Measured: 3 Years
Evaluate the volume of distribution of ProAgio
If there are sufficient participant data available, a population PK analyses will be conducted to identify covariates that may be significantly associated with the inter-individual variability for a particular PK parameter (e.g. clearance of volume of distribution).The NCI CPP may also conduct dose-response and/or exposure-response analyses that will assess PK/PD relationships with relevant biomarkers, clinical response, and adverse event data.
Measured: 3 Years
Rate of study drug elimination in research participants
58 study participants will have study drug concentration levels analyzed with regard to drug elimination. Results will be expressed in units of inverse time, i.e. 1/hr or 1/day.
Measured: 3 Years
Objective Response Rate (ORR)
Make a preliminary assessment of anti-tumor activity by measuring objective response rate (ORR),
Measured: 3 Years
Disease control rate (DCR).
Make a preliminary assessment of anti-tumor activity by measuring disease control rate at 18 weeks (DCR).
Measured: At 18 Weeks
Assess serum tumor marker CA19-9 or appropriate tumor specific marker.
Make a preliminary assessment of anti-tumor activity by measuring change in relevant serum tumor marker CA19-9 appropriate tumor specific marker.
Measured: Day 1 of each treatment cycle and 30 days after the last dose of study therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start29 Oct 2021
- Primary completion24 Apr 2025
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study includes a dose escalation arm, followed by an expansion arm at the ideal dose for participants with non-neuroendocrine pancreatic cancer.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProDa BioTech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anish Thomas, MBBS, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085548
- Sponsor's protocol ID
- 000194
- Other IDs
- 2R42CA217482-02
- Status last verified
- Apr 2026
- First submitted
- 10 Sep 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, for Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05085548
- Acronym / sponsor ID
- 000194
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ProDa BioTech, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study includes a dose escalation arm, followed by an expansion arm at the ideal dose for participants with non-neuroendocrine pancreatic cancer.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ProAgio Dose Levels (DL) 1,2,3, Drug: ProAgio Dose Levels (DL) 4,5,6, Drug: ProAgio Dose Levels 4a,5a,6aParticipants will receive ProAgio in escalating doses. |
| Expansion Biopsy Arm | Experimental | Drug: ProAgio Dose Levels 4a,5a,6aPre- and post-treatment tumor biopsy is optional for participants enrolled in the standard arm, but mandatory for participants enrolled in the biopsy arm. |
| Standard Arm | Experimental | Drug: ProAgio Dose Levels (DL) 4,5,6, Drug: ProAgio Dose Levels 4a,5a,6aParticipants will receive ProAgio at the RP2D and may elect to receive concurrent gemcitabine beginning with the start of Cycle 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProAgio Dose Levels (DL) 1,2,3Also: ACT50ProAgio is administered to study participants by intravenous injections once every 14 days. | Drug | Dose Escalation |
| ProAgio Dose Levels (DL) 4,5,6Also: ACT50ProAgio is administered to study participants by intravenous injections once every 7 days. | Drug | Dose Escalation, Standard Arm |
| ProAgio Dose Levels 4a,5a,6aAlso: ACT50, GemcitibineProAgio 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. | Drug | Dose Escalation, Expansion Biopsy Arm, Standard Arm |
Primary outcome
Determine Recommended Phase 2 Dose (RP2D)
Time frame: 3 Years
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.
9 secondary outcomes
Safety and Tolerability of ProAgio
Time frame: 3 Years
Evaluate the Maximum Plasma Concentration of ProAgio
Time frame: 3 Years
Evaluate the area under the curve of ProAgio
Time frame: 3 Years
Evaluate the Serum half-life of ProAgio
Time frame: 3 Years
Evaluate the volume of distribution of ProAgio
Time frame: 3 Years
Rate of study drug elimination in research participants
Time frame: 3 Years
Objective Response Rate (ORR)
Time frame: 3 Years
Disease control rate (DCR).
Time frame: At 18 Weeks
Assess serum tumor marker CA19-9 or appropriate tumor specific marker.
Time frame: Day 1 of each treatment cycle and 30 days after the last dose of study therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anish Thomas, MBBS, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ProAgio Dose Levels (DL) 1,2,3, ProAgio Dose Levels (DL) 4,5,6 and ProAgio Dose Levels 4a,5a,6a in people with Advanced Pancreatic Cancer and Solid Tumor Malignancies, run by ProDa BioTech, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Recommended Phase 2 Dose (RP2D) (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.