NCT05042128

The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Australasian Gastro-Intestinal Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	LSTA1	LSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC
DRUG	Gemcitabine Injection	Chemotherapy drug provided as solution to be administered via IV infusion.
DRUG	Nab paclitaxel	Chemotherapy drug provided as solution to be administered via IV infusion.

Timeline

• Start date: 2022-04-13
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2021-09-13
• Last updated: 2024-10-22

Locations

24 sites across 2 countries: Australia, New Zealand