ProAgio for Advanced Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: ProDa BioTech, LLC
Must not be taking: Steroids, Anticonvulsants
Disqualifiers: CNS tumors, Uncontrolled diseases, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new drug called ProAgio for safety and effectiveness in patients with advanced pancreatic cancer. Pancreatic cancer is very deadly, and current treatments are not very effective. ProAgio has shown good results in animal studies by treating the cancer and helping animals live longer.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be more than 14 days removed from your most recent standard or experimental drug treatment for your tumor.
What makes the drug ProAgio unique for treating advanced pancreatic cancer?
ProAgio is unique because it represents a novel approach in treating advanced pancreatic cancer, which has limited effective treatments and a high mortality rate. While traditional treatments focus on chemotherapy and surgery, ProAgio may offer a new mechanism of action or target, potentially improving outcomes for patients with this aggressive disease.
12345Eligibility Criteria
This trial is for adults over 18 with advanced solid tumors, including pancreatic cancer, who've had at least one prior treatment. They must have a tumor that can be biopsied or measurable disease and good organ function. Participants need to use contraception and cannot join if they're pregnant, have significant uncontrolled diseases, active infections, recent surgery or radiation therapy, untreated brain metastases, certain blood pressure or heart rate conditions.Inclusion Criteria
My cancer is confirmed and cannot be cured, according to a pathology lab.
Ability of subject to understand and the willingness to sign a written informed consent document
I can take care of myself but may not be able to do heavy physical work.
+9 more
Exclusion Criteria
I have been diagnosed with a primary brain tumor.
I do not have any active or uncontrolled infections.
I have not had uncontrolled bleeding in the last 28 days.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants will receive ProAgio in escalating doses to determine the maximum tolerated dose (MTD)
Variable, until MTD is determined
Expansion Cohort
Participants with advanced nonendocrine pancreatic adenocarcinoma will receive ProAgio at the MTD, with optional co-administration of gemcitabine
Until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Participant Groups
The study tests the safety of different dose levels of ProAgio in patients with various advanced solid tumors. It's a first-in-human Phase I trial where participants are given escalating doses to find out how much of this new drug can be safely administered.
3Treatment groups
Experimental Treatment
Group I: Standard ArmExperimental Treatment2 Interventions
Participants will receive ProAgio at the RP2D and may elect to receive concurrent gemcitabine beginning with the start of Cycle 2.
Group II: Expansion Biopsy ArmExperimental Treatment1 Intervention
Pre- and post-treatment tumor biopsy is optional for participants enrolled in the standard arm, but mandatory for participants enrolled in the biopsy arm.
Group III: Dose EscalationExperimental Treatment3 Interventions
Participants will receive ProAgio in escalating doses.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Cancer InstituteBethesda, MD
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Who Is Running the Clinical Trial?
ProDa BioTech, LLCLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Carcinoma of the body of pancreas in evolution: an aggressive disease affecting younger patients? [2007]Pancreatic body carcinoma has a poor prognosis with advanced disease at presentation. Recent experience at multidisciplinary team (MDT) meetings suggests increasing prevalence.
The role of surgery for pancreatic cancer: a 12-year review of patient outcome. [2021]Pancreatic cancer has a poor prognosis with
Multimodality treatment of locally advanced pancreatic cancer. [2019]The prognosis of locally advanced pancreatic cancer is poor (median survival 3-5 months). In view of the localized character of this disease several groups have explored the value of combined modality treatment. The conditions are that a good local treatment and an effective systemic treatment are available.
Advanced pancreatic cancer: The standard of care and new opportunities. [2020]Presentation of pancreatic cancer is localized, locally advanced or metastatic. With the later represented the main bulk (more than 80%). Despite the significant innovation in molecular analysis and therapeutic approach in many types of cancer in the last two decades, still the outcome of advanced pancreatic cancer is disappointing and the mortality rate approximately unchanged. In this mandated review we intended to highlight the standard of care and emerging agents for advanced pancreatic cancer treatment.
Advancements in Systemic Therapy for Pancreatic Cancer. [2023]Outcomes for patients with advanced pancreatic cancer have improved in the past 12 years, mainly because of progress made in systemic therapies. New treatment strategies for advanced pancreatic cancer include switch maintenance with cytotoxic therapies, induction maintenance, and the utilization of targeted agents for patients with actionable variants, as well as ongoing development of cytotoxic regimens, such as NALIRIFOX. The activity of immunotherapy has been disappointing to date, but novel combinations and identifying appropriate patient populations may further unlock its potential.