Certepetide Phase 1b/2a Continuous Infusion Trial In MPDAC

Study Overview

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

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

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.

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

DRUG: certepetide
DRUG: nab-paclitaxel
DRUG: gemcitabine
DRUG: placebo matching certepetide
DRUG: certepetide
DRUG: placebo matching certepetide
DRUG: placebo matching certepetide

LSTA1-P06

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-09-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-03
First Submitted that Met QC Criteria 2024-09-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-06
First Posted (ACTUAL) 2024-09-19	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

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 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 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: 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: 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
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 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

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

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

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: 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: 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

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

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

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Kristen K. Buck, MD, Lisata Therapeutics, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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