Health TrialsbyHealthPanel

A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer

ConditionsPancreatic Cancer, MetastaticPDAC - Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEngeneic Pty Limited

About this trial

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 nab-paclitaxel versus gemcitabine and nab-paclitaxel alone in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required.

Male or Female greater than or equal to 18 years of age.

Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.

Life expectancy ≥ 3 months in the opinion of the Investigator.

Disqualifiers

Subjects currently receiving any other investigational agent.

Unresolved (≥ Grade 1) non-hematological adverse events from prior anti-cancer therapy that is not controlled on maximal supportive therapy.

Significant pericardial effusions, pleural effusions, or ascites that requires intervention. Subjects who require drainage within the last four weeks are ineligible.

History of leptomeningeal or brain/CNS metastases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • E-EDV-D682

    Drug

    E-EDV-D682 is a product based on the EnGeneIC EDV™ technology. EDVs are bacterially derived nanocells 400 nm in diameter that can be packaged with a range of different chemotherapeutic drugs and specifically targeted to cancer cell receptors via single chain bispecific antibodies (BsAb). E-EDV-D682 packages a chemotherapeutic payload PNU159682 into the EDV which targets the epidermal growth factor (EGFR) on cancer cells via a BsAb.

  • EDV-GC

    Drug

    EDV-GC is a product based on the EnGeneIC EDV™ technology. EDVs are bacterially derived nanocells 400 nm in diameter that can be packaged with a range of different drugs. EDV-GC packages the immunomodulatory adjuvant aplha-galactosyl ceramide (GC) into the EDV and is designed to recruit anti-tumor immune cells.

  • Gemcitabine

    Drug

    Gemcitabine in combination with nab-paclitaxel is routinely used as second-line therapy in metastatic PDAC patients who have either progressed on or are intolerant to 5-FU based combination in the first line setting. In this trial the safety and efficacy of E-EDV-D682/GC will be tested in combination with a reference therapy - gemcitabine and nab-paclitaxel.

  • Nab paclitaxel.

    Drug

    Nab-paclitaxel in combination with gemcitabine is routinely used as second-line therapy in metastatic PDAC patients who have either progressed on or are intolerant to 5-FU based combination in the first line setting. In this trial the safety and efficacy of E-EDV-D682/GC will be tested in combination with a reference therapy - gemcitabine and nab-paclitaxel.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Cohort 2 Arm AExperimental treatment 4 interventions
Group B: Cohort 2 Arm BPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

All participants will be monitored for adverse events (AEs) and serious adverse events (SAEs) according to the CTCAE (Common Terminology Criteria for Adverse Events), Version 5 criteria. Incidence and severity of AEs will be reported for individual participants and treatment arms. The safety of Gemcitabine Nab-paclitaxel + E-EDV-D682/GC (Arm A) will be compared to Gemcitabine Nab-paclitaxel + placebo (Arm B).

Time frame
All adverse events will be monitored throughout the trial from the date of enrollment until 30 days after the last dose of study drug, on average 9 months.
2

Duration of time from the start of treatment that participants are still alive.

A primary objective of the randomized, blinded Phase IIa stage of the study is to examine the overall survival rate for each treatment arm. i.e. Gemcitabine Nab-paclitaxel + E-EDV-D682/GC (Arm A), compared to Gemcitabine Nab-paclitaxel + placebo (Arm B). Overall survival is defined as time from the date of first administration of drug to the date of death, regardless of cause. Kaplan Meier curves will be utilized to determine percentage and median survival. The primary hypotheses that the IMP treatment improves overall survival versus standard-of-care chemotherapy will be assessed using statistical models defined in the study protocol.

Time frame
Overall survival will be monitored from the date of first dose to the end of the treatment period (on average 9 months), then at 3 month intervals following discontinuation of study treatment for a minimum period of 12 months.

Secondary outcomes

1

The number of days from the date of first administration of EDVs to the date of radiological evidence of disease progression

Progression free survival (PFS) will be calculated from all participants as the number of days from the date of first administration of EDVs to the date of radiological evidence of disease progression (date of MRI scan) or death, regardless of cause. A comparison of the PFS will be made between the two treatment Arms.

Time frame
Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until disease progression is confirmed by iRECIST or death, whichever comes first, up to 24 months.
2

Percentage of participants with immune complete response (iCR) or immune partial response (iPR)

The Objective Response Rate (ORR) will be measured as the percentage of participants with immune complete response (iCR) or immune partial response (iPR). A comparison of the ORR will be made between the two treatment Arms.

Time frame
Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until the participant is withdrawn from treatment (up to 24 months).
3

Time from initial response to disease progression

The Duration of Response (DOR) will be measured as the time from the initial complete or partial response until disease progression or death, whichever comes first. A comparison of the DOR will be made between the two treatment Arms.

Time frame
Imaging will be performed at baseline (screening) and at the completion of every cycle of treatment (8 weeks) until the participant has confirmed disease progression per iRECIST or death, whichever comes first, up to 24 months.
4

The proportion of participants with a disease response at 4 months after treatment initiation

The Disease Control Rate (DCR) will be measured as the proportion of participants with immune complete response (iCR), immune partial response (iPR) and immune stable disease (iSD) at 4 months after treatment initiation. A comparison of the DCR will be made between the two treatment Arms.

Time frame
Imaging will be performed at baseline (screening) and at the completion of cycle 2 of treatment (16 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Engeneic Pty Limited

Lead sponsor

Herbert Irving Comprehensive Cancer Center

Collaborator

Source ClinicalTrials.gov
Apply now