Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC
- Conditions
- Pancreas CancerPancreatic CarcinomaPancreas AdenocarcinomaPancreatic Ductal AdenocarcinomaUnresectable Pancreatic CancerMetastatic Pancreatic CancerPDACPDAC - Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT06592664
- Lead Sponsor
- Lisata Therapeutics, Inc.
- 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
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 30
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion certepetide - SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion nab-paclitaxel - SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion gemcitabine - SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion placebo matching certepetide - SoC chemotherapy plus two certepetide IV pushes and placebo infusion nab-paclitaxel - SoC chemotherapy plus two certepetide IV pushes and placebo infusion gemcitabine - SoC chemotherapy plus two placebo IV pushes and placebo infusion nab-paclitaxel - SoC chemotherapy plus two placebo IV pushes and placebo infusion gemcitabine - SoC chemotherapy plus two certepetide IV pushes and placebo infusion certepetide - SoC chemotherapy plus two certepetide IV pushes and placebo infusion placebo matching certepetide - SoC chemotherapy plus two placebo IV pushes and placebo infusion placebo matching certepetide -
- Primary Outcome Measures
Name Time Method Incidence of adverse events 30 days after treatment discontinuation 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
FirstHealth of the Carolinas, Inc.
🇺🇸Pinehurst, North Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States