SGT-53 + Gemcitabine + nab-paclitaxel for Pancreatic Cancer

Overseen By Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SynerGene Therapeutics, Inc.

Must not be taking: Antibiotics, Coumadin, Steroids, others

Disqualifiers: Cardiac disease, Infections, Hypertension, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for individuals with metastatic pancreatic cancer that has spread. The study examines the safety and effectiveness of SGT-53 (an experimental treatment), gemcitabine, and nab-paclitaxel in halting cancer growth for at least 5.5 months. Ideal participants have stage IV pancreatic cancer with measurable tumors and have not yet received chemotherapy for this condition. The trial aims to assess the treatment's effectiveness and side effects. As a Phase 2 trial, the research focuses on evaluating the treatment's efficacy in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like Coumadin, systemic steroids, or investigational agents. It's best to discuss your specific medications with the trial team.

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

Research has shown that combining SGT-53 with the cancer drugs gemcitabine and nab-paclitaxel is generally well-tolerated by patients. Studies have demonstrated significant benefits for people with pancreatic cancer, particularly those who did not respond to other treatments, when SGT-53 is added to these drugs. Although detailed safety information is not yet available, the ongoing study phase suggests that the treatment is reasonably safe.

Gemcitabine and nab-paclitaxel are commonly used together to treat cancer and can cause side effects like tiredness and low blood cell counts, which are usually manageable. Prospective trial participants should be aware of these typical reactions to help prepare. Discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for pancreatic cancer involve chemotherapy drugs like gemcitabine and nab-paclitaxel, which work by attacking rapidly dividing cells. But SGT-53 is unique because it uses a targeted gene therapy approach. SGT-53 delivers a piece of DNA designed to boost the function of a tumor-suppressing gene, potentially enhancing the effectiveness of standard chemotherapy. This targeted mechanism allows it to aim directly at cancer cells, offering a new hope for improved outcomes in a notoriously tough-to-treat cancer. Researchers are excited about SGT-53 because it could significantly enhance the impact of existing treatments, leading to better responses in patients.

What evidence suggests that this combination therapy could be effective for pancreatic cancer?

Studies have shown that combining gemcitabine and nab-paclitaxel effectively treats pancreatic cancer, with earlier research indicating a response rate of 56.67%. This trial tests the addition of SGT-53 to this combination. SGT-53 may increase cancer cells' sensitivity to these drugs, potentially enhancing the treatment's effectiveness. Although more research is needed for confirmation, early results suggest that this combination could help prevent the cancer from growing and spreading for a longer period. ^{2 3 4 6 7}

Who Is on the Research Team?

Minal Barve, MD

Principal Investigator

Mary Crowley Cancer Research Center

Are You a Good Fit for This Trial?

This trial is for adults with stage IV metastatic pancreatic adenocarcinoma who haven't had chemotherapy, radiotherapy, or investigational therapy for metastatic disease. They must have a life expectancy of at least 3 months, acceptable organ and blood function, no serious infections or heart conditions, not be pregnant or nursing, and willing to use contraception.

Inclusion Criteria

Your bilirubin levels are not too high.

You are able to perform daily activities without any help or only need a little help.

You are expected to live for at least 3 more months.

Exclusion Criteria

Treated with antibiotics for infection within one week prior to study entry

Pregnant or nursing women

You are taking Coumadin or similar medications, except for keeping your vein access lines open.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SGT-53 plus gemcitabine/nab-paclitaxel for 7 weeks, with bi-weekly and weekly infusions

7 weeks

Bi-weekly visits in weeks 1-3, weekly visits in weeks 4-7

Follow-up

Participants are monitored for safety and effectiveness after treatment

5.5 months

Extension

Participants who respond to treatment may receive additional courses of therapy at investigator discretion

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• nab-paclitaxel
• SGT-53

Trial Overview The study tests the combination of SGT-53 (a gene therapy) with gemcitabine/nab-paclitaxel (chemotherapy drugs) in patients with advanced pancreatic cancer. It's an open label Phase II trial focusing on safety and how well it works to stop cancer progression within 5.5 months.

How Is the Trial Designed?

Group I: SGT-53 with gemcitabine/nab-paclitaxel Experimental Treatment 3 Interventions

A course of therapy will include 7 weeks of treatment. SGT-53, at 3.6 mg DNA/infusion, will be administered bi-weekly on days 1 and 5 in weeks 1-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7. Patients who are responding to treatment may receive two additional courses (7 weeks) of SGT-53/gemcitabine/nab-paclitaxel therapy at investigator discretion. If still responding to treatment, they may continue on SGT-53/gemcitabine/nab-paclitaxel at investigator discretion with the approval of the sponsor.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

SynerGene Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

90+

Citations

1. npcf.us npcf.us/clinical-trials/study-of-combined-sgt-53-plus-gemcitabine-nab-paclitaxel-for-metastatic-pancreatic-cancer/

Study Of Combined SGT-53 Plus Gemcitabine/Nab ... This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02340117/study-of-combined-sgt-53-plus-gemcitabine-nab-paclitaxel-for-metastatic-pancreatic-cancer

Study of Combined SGT-53 Plus Gemcitabine/Nab ... The objective of the study is to evaluate the safety, tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9273318/

Study of Gemcitabine Plus Nab-Paclitaxel-Based ... The response rate of 56.67% and the promising PFS are strong arguments for clinically using this combination in pancreatic carcinoma. To the best of our ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT02340117/

Trial | NCT02340117 This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02023021

Nab-paclitaxel Combined With Gemcitabine as Adjuvant ... The present study is intended to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel as adjuvant chemotherapy in treating ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.4139

A phase II trial combining tumor-targeting TP53 gene ... Our data suggest a clinically meaningful benefit of adding SGT-53 to GEM/ABX particularly for second-line PAC patients, most of whom had failed prior FFX ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12484532/

Efficacy and safety of the S-1, nab-paclitaxel, and gemcitabine ... Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies worldwide, with a 5-year survival rate of less than 10% (1).