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

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)

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

Study Overview

• Status: Withdrawn
• Conditions: Pancreas Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreas Cancer; Pancreatic Carcinoma; Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: certepetide; Drug: nab-paclitaxel; Drug: gemcitabine; Drug: placebo matching certepetide; Drug: certepetide; Drug: placebo matching certepetide; Drug: placebo matching certepetide

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas, Inc.
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been treated previously and be eligible for treatment with nab-paclitaxel and gemcitabine
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy ≥ 3 months
• At least one measurable tumor lesion as assessed by RECIST 1.1
• Adequate organ and marrow function
• Adequate contraception

Exclusion Criteria:

• Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents
• Received prior anti-cancer therapy for their pancreatic cancer

• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results, including but not limited to:

  • Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
  • Active infection (viral, fungal, or bacterial) requiring systemic therapy
  • Known active hepatitis B virus, hepatitis C virus, or HIV infection
  • Active tuberculosis as defined per local guidance
  • History of allogeneic tissue/solid organ transplant
  • Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
  • Pregnant or breastfeeding
  • Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
• History or clinical evidence of symptomatic central nervous system (CNS) metastases
• Enrolled in any other clinical protocol or investigational trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion	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; Other Names: LSTA1; CEND-1; Drug: nab-paclitaxel; nab-paclitaxel 125 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days; Other Names: Abraxane; 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; Other Names: LSTA1; CEND-1; 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
Experimental: SoC chemotherapy plus two certepetide IV pushes and placebo infusion	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; Other Names: LSTA1; CEND-1; Drug: nab-paclitaxel; nab-paclitaxel 125 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days; Other Names: Abraxane; 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; Other Names: LSTA1; CEND-1; 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
Active Comparator: SoC chemotherapy plus two placebo IV pushes and placebo infusion	Drug: nab-paclitaxel; nab-paclitaxel 125 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days; Other Names: Abraxane; 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study	30 days after treatment discontinuation

Collaborators and Investigators

• Sponsor: Lisata Therapeutics, Inc.
• Investigators: Study Chair: Kristen K. Buck, MD, Lisata Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Chemotherapy; Chemo
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Carcinoma; Pancreatic Neoplasms; Adenocarcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel
• Other Study ID Numbers: LSTA1-P06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No