NCT02340117

Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer

Active, enrolled Phase 2 Last updated 28 May 2025

What this trial tests

Phase 2 trial testing SGT-53 in Metastatic Pancreatic Cancer in 28 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2015

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	SynerGene Therapeutics, Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 January 2015
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

• SGT-53 — full drug profile →
• nab-paclitaxel (nab-paclitaxel) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →

Sponsor

SynerGene Therapeutics, Inc.

Who can join

18 and older, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression free survival (PFS) at 5.5 months
  Time frame: 5.5 months
  PFS5.5mos will be assessed by objective radiographic assessment
• Objective response rate (ORR)
  Time frame: Up to 5 years
  ORR will be assessed by objective radiographic assessment using RECIST 1.1 criteria

Sponsor's own description

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 metastatic pancreatic cancer. The objective of the study is to evaluate the safety, tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month (PFS5.5mos)) of this combination therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drugging p53 in cancer: one protein, many targets.
   Hassin O, Oren M. · · 2023 · cited 496× · PMID 36216888 · DOI 10.1038/s41573-022-00571-8
2. Nanomedicine in cancer therapy.
   Fan D, Cao Y, Cao M, Wang Y, et al · · 2023 · cited 454× · PMID 37544972 · DOI 10.1038/s41392-023-01536-y
3. Pancreatic Ductal Adenocarcinoma: Current and Evolving Therapies.
   Adamska A, Domenichini A, Falasca M. · · 2017 · cited 429× · PMID 28640192 · DOI 10.3390/ijms18071338
4. Targeting iron metabolism in drug discovery and delivery.
   Crielaard BJ, Lammers T, Rivella S. · · 2017 · cited 279× · PMID 28154410 · DOI 10.1038/nrd.2016.248
5. Lipid nanoparticle technology for therapeutic gene regulation in the liver.
   Witzigmann D, Kulkarni JA, Leung J, Chen S, et al · · 2020 · cited 272× · PMID 32622021 · DOI 10.1016/j.addr.2020.06.026
6. Nanoparticles in the clinic: An update post COVID-19 vaccines.
   Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
7. Altered Iron Metabolism and Impact in Cancer Biology, Metastasis, and Immunology.
   Brown RAM, Richardson KL, Kabir TD, Trinder D, et al · · 2020 · cited 204× · PMID 32328462 · DOI 10.3389/fonc.2020.00476
8. Design considerations for nanotherapeutics in oncology.
   Stylianopoulos T, Jain RK. · · 2015 · cited 181× · PMID 26282377 · DOI 10.1016/j.nano.2015.07.015