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

NCT06592664 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: LSTA1-P06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Keywords

Chemo; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion

EXPERIMENTAL

Drug: certepetide; Drug: nab-paclitaxel; Drug: gemcitabine; Drug: placebo matching certepetide

SoC chemotherapy plus two certepetide IV pushes and placebo infusion

EXPERIMENTAL

Drug: nab-paclitaxel; Drug: gemcitabine; Drug: certepetide; Drug: placebo matching certepetide

SoC chemotherapy plus two placebo IV pushes and placebo infusion

ACTIVE COMPARATOR

Drug: nab-paclitaxel; Drug: gemcitabine; Drug: placebo matching certepetide

Interventions

certepetide DRUG

certepetide given as an IV push over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given

Also known as: LSTA1, CEND-1

SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion

nab-paclitaxel DRUG

nab-paclitaxel 125 mg/m\^2 IV administered on Day 1, 8, and 15 every 28 days

Also known as: Abraxane

SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion; SoC chemotherapy plus two certepetide IV pushes and placebo infusion; SoC chemotherapy plus two placebo IV pushes and placebo infusion

gemcitabine DRUG

gemcitabine 1000 mg/m\^2 IV administered on Day 1, 8, and 15 every 28 days

SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion; SoC chemotherapy plus two certepetide IV pushes and placebo infusion; SoC chemotherapy plus two placebo IV pushes and placebo infusion

placebo matching certepetide DRUG

placebo given as two IV pushes over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given

SoC chemotherapy plus two placebo IV pushes and placebo infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisata Therapeutics, Inc.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kristen K. Buck, MD

  Lisata Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2040
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share