Status:
WITHDRAWN
Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC
Lead Sponsor:
Lisata Therapeutics, Inc.
Conditions:
Pancreas Cancer
Pancreatic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2030
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2040
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06592664
Start Date
January 1 2030
End Date
January 1 2040
Last Update
June 6 2025
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