ProAgio + Chemotherapy for Pancreatic Cancer

Overseen By Damon R Michaels

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ProDa BioTech, LLC

Must be taking: Gemcitabine, Nab paclitaxel

Must not be taking: Hematopoietic growth factors

Disqualifiers: Peripheral neuropathy, CNS lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

28 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, certain medications like hematopoietic growth factors must be stopped 2 weeks before starting the trial, unless they were started earlier and are stable.

What data supports the effectiveness of the drug ProAgio in combination with chemotherapy for pancreatic cancer?

Chemotherapy has shown a slight survival benefit and improved quality of life for some patients with advanced pancreatic cancer, although its overall activity is low. Gemcitabine, a chemotherapy drug, is approved in some countries for treating advanced pancreatic cancer and has been shown to improve survival and well-being in certain cases. ^{1 2 3 4 5}

What is the purpose of this trial?

This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC)

Research Team

Mehmet Akce, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults with stage IV pancreatic ductal adenocarcinoma who haven't been treated before. They must have good liver, kidney, and blood health as shown by specific medical tests. Participants need a tumor that can be safely biopsied and should not have had certain other cancer treatments recently.

Inclusion Criteria

My diagnosis is stage IV pancreatic cancer.

I have a tumor that can be safely biopsied.

Written informed consent must be obtained prior to any screening procedures

Exclusion Criteria

I have no other cancer besides the one being treated in this study, with some exceptions.

I have a brain lesion that hasn't been treated, but it meets certain conditions.

Received an investigational drug or used an invasive investigational medical device within a defined timeframe

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

ProAgio combined with gemcitabine and nab paclitaxel is administered to study participants by intravenous injections on days 1, 8, 15, 22 every 4-week Cycle to determine the recommended RP2D.

16 weeks

4 visits per cycle (in-person)

Dose Expansion

An expansion cohort of 12 subjects will confirm the safety of the regimen and provide preliminary data on the activity of both ProAgio monotherapy and ProAgio + GnP.

16 weeks

4 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with response evaluated every 2 months using RECIST criteria.

8 weeks

Treatment Details

Interventions

• ProAgio

Trial Overview The trial is testing different doses of ProAgio combined with chemotherapy drugs gemcitabine and nab paclitaxel in patients. It's to see how safe it is, how the body processes it, and if it works against metastatic pancreatic cancer.

Participant Groups

Group I: Standard Arm Experimental Treatment 2 Interventions

Participants will receive ProAgio at the RP2D combined with gemcitabine and nab paclitaxel is administered to study participants by intravenous injections on days 1, 8, 15, 22 every 4-week Cycle. Other Names: ACT50, G-nP: Gemcitabine and nab-Paclitaxel

Group II: Dose Escalation Experimental Treatment 2 Interventions

ProAgio Dose Levels (DL) 1,2,3,4 ProAgio combined with gemcitabine and nab paclitaxel is administered to study participants by intravenous injections on days 1, 8, 15, 22 every 4-week Cycle. Other Names: ACT50, G-nP: Gemcitabine and nab-Paclitaxel

Who Is Running the Clinical Trial?

ProDa BioTech, LLC

Lead Sponsor

Trials

3

Recruited

140+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Georgia State University

Collaborator

Trials

71

Recruited

33,600+

Findings from Research

In a study of 49 patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDA) treated with FOLFIRINOX, the overall response rate was 41%, with a median overall survival of 18.4 months for locally advanced cases and 12.2 months for metastatic cases, indicating significant efficacy of the treatment.

The treatment was associated with notable toxicities, including neutropenia (29%) and fatigue (18%), but careful patient selection and monitoring of biomarkers like CA 19-9 can help improve outcomes and manage risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FOLFIRINOX for locally advanced or metastatic pancreatic ductal adenocarcinoma: the Royal Marsden experience. Moorcraft, SY., Khan, K., Peckitt, C., et al.[2022]

Chemotherapy for advanced pancreatic cancer shows low overall activity but can provide a slight survival benefit and improve quality of life for some patients, as indicated by a systematic review of eight small randomized trials.

While gemcitabine is an approved treatment in some countries, there is no standard chemotherapy regimen established, and conclusive evidence for the use of adjuvant chemotherapy remains lacking due to the small number of patients in relevant trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in the treatment of cancer of the pancreas. Glimelius, B.[2022]

Pancreatic adenocarcinoma is often diagnosed at advanced stages, with 80% of cases being inoperable or metastatic, leading to a low 1-year survival rate of 20-50% depending on treatment and patient condition.

Adjuvant chemotherapy after surgery can significantly improve survival rates, potentially doubling the chances of survival, while new evidence-based treatment options are being integrated into clinical practice to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current standards in the treatment of pancreatic cancer]. Pelzer, U., Riess, H.[2015]

Neoadjuvant chemotherapy, given before surgery, is safe and effective for patients with resectable pancreatic cancer, potentially improving their nutritional status and leading to a median survival of 26.5 months, as shown in a recent phase II trial.

The NEOPAC phase III trial will compare the efficacy of neoadjuvant chemotherapy followed by surgery against surgery followed by adjuvant chemotherapy, with a primary focus on progression-free survival in 310 patients, aiming to provide valuable insights into treatment outcomes for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). Heinrich, S., Pestalozzi, B., Lesurtel, M., et al.[2022]

In a phase 3 trial involving 368 patients with completely resected pancreatic cancer, adjuvant treatment with gemcitabine for 6 months significantly improved both disease-free survival (13.4 months vs. 6.7 months) and overall survival (20.7% vs. 10.4% at 5 years) compared to observation alone.

The study demonstrated that gemcitabine not only prolongs the time before cancer recurrence but also enhances overall survival rates, providing strong evidence for its use in patients after surgical removal of pancreatic tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. Oettle, H., Neuhaus, P., Hochhaus, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

FOLFIRINOX for locally advanced or metastatic pancreatic ductal adenocarcinoma: the Royal Marsden experience. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Chemotherapy in the treatment of cancer of the pancreas. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Current standards in the treatment of pancreatic cancer]. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. [2022]