NCT06592664

Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lisata Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma. The main questions it aims to answer are: * is the new drug plus standard treatment safe and tolerable * is the new drug plus standard treatment more effective than standard treatment Participants will: * Visit the clinic three times every 28 days for treatment and tests * Have CT or MRI scans every 8 weeks while on treatment

Detailed description

This is a Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study evaluating a single intravenous push of certepetide followed by a continuous infusion of certepetide over 4 hours when added to standard of care (SoC) versus two intravenous pushes of certepetide given 4 hours apart when added to SoC, versus SoC alone in people with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The study will consist of a screening period, a run-in period, a treatment period, an end-of-treatment follow-up visit, and a long-term follow up period. Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period. Once eligibility is confirmed, participants will be randomized to one of the three treatment groups. During the 3-day run-in period, participants will only receive the LSTA1 or placebo components of their randomized treatment regimen. After the 3-day run-in, Cycle 1 of treatment will commence. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.

Conditions

• Pancreas Cancer
• Pancreatic Carcinoma
• Pancreas Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Unresectable Pancreatic Cancer
• Metastatic Pancreatic Cancer
• PDAC
• PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	certepetide	certepetide given as an IV push over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given
DRUG	nab-paclitaxel	nab-paclitaxel 125 mg/m\^2 IV administered on Day 1, 8, and 15 every 28 days
DRUG	gemcitabine	gemcitabine 1000 mg/m\^2 IV administered on Day 1, 8, and 15 every 28 days
DRUG	placebo matching certepetide	placebo given as two IV pushes over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given
DRUG	certepetide	certepetide given as two IV pushes over 1 minute when standard treatment(s) are given
DRUG	placebo matching certepetide	placebo given as an IV infusion over 4 hours when standard treatment(s) are given
DRUG	placebo matching certepetide	certepetide given as a slow IV push over 1 minute when standard treatment(s) are given

Timeline

• Start date: 2030-01-01
• Primary completion: 2035-01-01
• Completion: 2040-01-01
• First posted: 2024-09-19
• Last updated: 2025-06-06

Regulatory

• FDA-regulated drug study