NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

A Phase I Trial of ProAgio, an anti- alpha-v-beta3 Integrin Cytotoxin, for Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Pancreatic Ductal Adenocarcinoma;
pegylated peptide drug;
Endothelial Cells;

Recruitment Keyword(s)



Pancreatic Cancer;
Solid Tumors

Investigational Drug(s)

ProAgio (ACT-50)

Investigational Device(s)



Drug: ProAgio
Drug: Gemcitabine

Supporting Site

National Cancer Institute


Pancreatic cancer is the third most common cause of cancer death in the United States. People are usually diagnosed at an advanced stage. But even those with early stage disease have a poor prognosis. Researchers want to see if a new drug can help.


To find the safest dose of ProAgio to treat advanced pancreatic and other types of cancer.


People ages 18 and older with a solid tumor that is not curable with available standard therapies.


Participants will be screened with a medical record review and physical exam. They will have blood and urine tests. They will have an electrocardiogram to test heart function. They may have imaging scans and/or bone scans. For these, they may have a contrast agent injected into their arm.

Treatment will be given in 14-day cycles. Participants will receive ProAgio as 30-minute intravenous injections once every cycle. They may be given medicine for side effects. For the first 3 cycles, they will be admitted to the NIH Clinical Center for at least 48 hours. They may receive ProAgio until their disease gets worse, they have serious side effects, or they decide to stop treatment.

Participant will have several study visits. At these visits, they will repeat some screening tests. They will have imaging scans every 3 cycles starting with cycle 4. They may have a tumor biopsy.

About 4 weeks after treatment ends, participants will have a safety visit. Then they will be contacted every 3 months by phone for 1 year.

--Back to Top--



-Histologic or cytologic diagnosis of a solid tumor malignancy for which no curative therapy exists.

-For expansion cohort: histologic or cytologic diagnosis of non-neuroendocrine pancreatic cancer. Participants with mixed acinar-neuroendocrine histology are permitted.

-Participants in the Biopsy Arm of the expansion cohort must have disease amenable to safe biopsy and willingness to undergo the procedure.

-Participants must have received at least one prior systemic treatment for advanced disease. Participants must be more than 14 days removed from most recent standard of care or experimental drug treatment for their tumor

-Participants in the dose escalation cohort must have evaluable disease, either by clinical exam, biochemical markers (including but not limited to CA 19-9 serum tumor marker for pancreatobiliary cancer participants, or other appropriate tumor marker in other tumor types), and/or radiographic studies.

-Participants in the expansion cohort must have measurable disease, per RECIST 1.1.

-Age >=18 years. Because no dosing or adverse event data are currently available on the use of ProAgio in participants <18 years of age, children are excluded from this study.

-ECOG performance status <=2 (Karnofsky >= 60%).

-Participants must have adequate organ and marrow function as defined below:

--absolute neutrophil count >=1,000/mcL

--hemoglobin >=9 g/ dL

--platelets >=75,000/mcL

--AST(SGOT)/ALT(SGPT) <= 2.5 x ULN. AST and ALT (up to 5x ULN is permitted for participants with liver metastases)

--Total bilirubin <=1.5 X institutional ULN

--creatinine within normal institutional limits


--creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal

--Serum albumin > 2.5 mg/dL without intravenous supplementation

-Participants must have:

--Baseline QTcF interval of <= 470 ms

--Baseline resting heart rate > 45 beats per minute and <100 beats per minute

-Women of child-bearing potential (WOCBP) and men must agree to use an effective method of contraception as follows:

--Women of child-bearing potential (WOCBP) 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).

--Men 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 men with female partners of childbearing potential to ask female partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization.

-Ability of subject to understand and the willingness to sign a written informed consent document


-Diagnosis of primary malignant CNS tumor

-Participants 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.

-Participants 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 women are excluded from this study because the study drug(s) are agents 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 the study drug(s), breastfeeding should be discontinued if the mother is treated with the study drug(s).

-Participants with leptominengeal 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: Participants 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.

-Participants who have undergone a recent minor surgical procedure (within <=14 days) such as biliary stenting or major surgical procedure (within <= 28 days) are excluded.

-Participants who have undergone recent (within <=14 days) external beam radiation therapy are excluded.Those who have undergone recent (within <= 28 days) treatment with radioactive therapeutics (such as Y90 or radio-immune conjugates) are ineligible.

-Participants with uncontrolled bleeding episodes <=28 days prior to enrollment are excluded.

-Participants with active or uncontrolled infections are excluded.

-Participants with HIV and detectable viral load are excluded. Patents on appropriate highly active anti-retroviral therapy with undetectable viral load are eligible.

-Participants 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.

-Participants 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 are excluded.

-Participants 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.

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Christine C. Alewine, M.D.
National Cancer Institute (NCI)
NIHBC 37 BG RM 5116B
(240) 760-6146

NCI Medical Oncology Referral Office
National Cancer Institute (NCI)

(888) 624-1937

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


--Back to Top--