EDV Nanocell Therapy + Chemotherapy for Pancreatic Cancer

(Carolyn-USA Trial)

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Engeneic Pty Limited

Must not be taking: QTc prolonging medicines

Disqualifiers: Brain metastases, Uncontrolled diabetes, others

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EDV Nanocell Therapy, a type of targeted therapy, to determine its safety and potential to extend the lives of people with pancreatic cancer. Researchers compare this new treatment combined with chemotherapy drugs (gemcitabine and nab-paclitaxel) to chemotherapy drugs alone. It targets individuals whose pancreatic cancer has spread and worsened after initial treatment. Ideal candidates for this trial have pancreatic cancer that has metastasized and not responded to first-line treatment. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering a chance to be among the first to benefit from this innovative therapy.

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, it mentions that QTc interval prolonging medicines should be reviewed and minimized if possible, so you might need to discuss this with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that EDV Nanocell Therapy, combined with chemotherapy drugs like gemcitabine and nab-paclitaxel, is generally safe for people with advanced pancreatic cancer. Earlier studies reported few side effects and noted that patients maintained their weight. The therapy was well-tolerated in these trials, without causing major problems. Although research is still in its early stages, these results suggest the treatment could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

EDV Nanocell Therapy is unique because it employs nanocell technology to deliver cancer-fighting agents directly to tumor cells. Unlike the standard chemotherapy options for pancreatic cancer, which often include drugs like gemcitabine and nab-paclitaxel, EDV Nanocell Therapy uses engineered nanocells to enhance precision in targeting cancer cells, potentially reducing side effects. Researchers are excited about this approach because it promises to increase the effectiveness of the treatment while minimizing damage to healthy cells, which is a significant limitation of current therapies.

What evidence suggests that EDV Nanocell Therapy might be an effective treatment for pancreatic cancer?

In this trial, participants in Cohort 2 Arm A will receive EDV Nanocell Therapy combined with gemcitabine and nab-paclitaxel. Research shows that this combination may help treat advanced pancreatic cancer. Earlier studies demonstrated improved survival rates for patients with advanced pancreatic cancer, with many experiencing stable disease. Specifically, 47.1% of patients had stable disease, and one patient experienced partial tumor shrinkage. Some patients lived longer than six months, with the longest survival reaching 19.7 months. The treatment caused few side effects and helped patients maintain their weight. These results suggest that EDV Nanocell Therapy could be a viable option for those whose cancer has worsened despite other treatments. ^{1 3 5 6 7}

Who Is on the Research Team?

Dr Jennifer MacDiarmid, Ph.D

Principal Investigator

Engeneic Pty Limited

Dr Himanshu Brahmbhatt, Ph.D

Principal Investigator

Engeneic Pty Limited

Dr Linda Y.Wu, MD

Principal Investigator

Columbia University Medical Center/ Herbert Irving Pavilion

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic pancreatic ductal adenocarcinoma (PDAC) who have seen their cancer progress despite previous treatments. Participants must meet certain health standards to be eligible.

Inclusion Criteria

Life expectancy ≥ 3 months in the opinion of the Investigator

Measurable disease as per iRECIST criteria

Albumin level > 3.0 g/dl

Exclusion Criteria

I have high calcium levels in my blood that need treatment.

Subjects currently receiving any other investigational agent

Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Safety Run-in

Initial safety run-in phase to assess dose limiting toxicity with E-EDV-D682/GC in combination with gemcitabine and nab-paclitaxel

4 weeks

Bi-weekly visits for 3 weeks, treatment-free week in week 4

Randomized Treatment

Participants receive either E-EDV-D682/GC with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel with placebo

16 weeks

Weekly visits for 7 weeks, treatment-free week in week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-35 days

Long-term Follow-up

Overall survival and progression-free survival monitored at 3-month intervals

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EDV Nanocell Therapy

Trial Overview The study tests the combination of E-EDV-D682/GC with gemcitabine and nab-paclitaxel against the standard treatment of just gemcitabine and nab-paclitaxel, aiming to improve overall survival in PDAC patients.

How Is the Trial Designed?

Group I: Cohort 2 Arm A Experimental Treatment 4 Interventions

E-EDV-D682/GC with gemcitabine and nab-paclitaxel

Group II: Cohort 2 Arm B Placebo Group 2 Interventions

gemcitabine and nab-paclitaxel with placebo

Who Is Running the Clinical Trial?

Engeneic Pty Limited

Lead Sponsor

Trials

2

Recruited

30+

Herbert Irving Comprehensive Cancer Center

Collaborator

Trials

36

Recruited

1,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37976042/

Phase I/IIa Trial in Advanced Pancreatic Ductal ... Conclusions: E-EDV-D682/GC provided significant OS, minimal side effects, and weight stabilization in patients with advanced PDAC. Advanced PDAC ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07049055

A Clinical Trial to Evaluate EDV Nanocell Therapy With ... The purpose of this study is to evaluate the safety and tolerability and overall survival (OS) of E-EDV-D682/GC in combination with gemcitabine and ...

3. aacrjournals.org aacrjournals.org/clincancerres/article-abstract/30/2/304/733203/Phase-I-IIa-Trial-in-Advanced-Pancreatic-Ductal?redirectedFrom=fulltext

Phase I/IIa Trial in Advanced Pancreatic Ductal ... Of the ES, 47.1% achieved stable disease and one partial response. Ten subjects in the ES survived over 6 months, the longest 19.7 months. During treatments, ...

4. actr.amegroups.org actr.amegroups.org/article/view/9697/html

Nanoparticle-based drug delivery in advanced pancreatic ... Pancreatic ductal adenocarcinoma (PDAC) has a dismal 5-year overall survival (OS) for all stages of disease which has only increased to 12% ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.4632

Interim data: Phase I/IIa study of EGFR-targeted EDV ... This planned safety analysis of an ongoing first-in-human, open label Phase I/IIa study in patients with treatment-refractory metastatic pancreatic cancer,

6. aacrjournals.org aacrjournals.org/clincancerres/article/30/2/304/733203/Phase-I-IIa-Trial-in-Advanced-Pancreatic-Ductal

Phase I/IIa Trial in Advanced Pancreatic Ductal ... The results in this trial show that a super-cytotoxic drug packaged in EDV can be safely administered systemically in human patients with cancer and can be used ...

7. academic.oup.com academic.oup.com/oncolo/article/30/3/oyae267/7814737

Recurrent pancreatic cancer treated with N-803 and PD-L1 t ... This article presents a case report for a patient who had received 3 lines of therapy for recurrent metastatic pancreatic cancer and who ...