LSTA1 Phase 1b/2a Continuous Infusion Trial in MPDAC

Phase 1

Not yet recruiting

• Conditions: Pancreas Cancer; Pancreatic Carcinoma; Pancreas Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT06592664
• Lead Sponsor: Lisata Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - Histologically or cytologically confirmed metastatic pancreatic ductal<br> adenocarcinoma that is considered unresectable<br><br> - Documented disease progression on first-line standard or modified FOLFIRINOX<br> treatment and be eligible for second-line treatment with nab-paclitaxel and<br> gemcitabine<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1<br><br> - Life expectancy = 3 months<br><br> - At least one measurable tumor lesion as assessed by RECIST 1.1<br><br> - Adequate organ and marrow function<br><br> - Adequate contraception<br><br>Exclusion Criteria:<br><br> - Concurrent use of any other anti-cancer therapy including chemotherapy, targeted<br> therapy, immunotherapy, or biological agents<br><br> - Received prior anti-cancer therapy for their pancreatic cancer other than standard<br> or modified FOLFIRINOX<br><br> - Any condition or comorbidity that, in the opinion of the investigator, would<br> interfere with evaluation of study treatment or interpretation of subject safety or<br> study results, including but not limited to:<br><br> - Any major surgery or irradiation less than 4 weeks prior to baseline disease<br> assessment<br><br> - Active infection (viral, fungal, or bacterial) requiring systemic therapy<br><br> - Known active hepatitis B virus, hepatitis C virus, or HIV infection<br><br> - Active tuberculosis as defined per local guidance<br><br> - History of allogeneic tissue/solid organ transplant<br><br> - Prior malignancy requiring active treatment within the previous 3 years except<br> for locally curable cancers that have been apparently cured, such as basal or<br> squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of<br> the prostate, cervix, or breast<br><br> - Pregnant or breastfeeding<br><br> - Clinically significant or symptomatic cardiovascular/cerebrovascular disease<br> (incl. myocardial infarction, unstable angina, symptomatic congestive heart<br> failure, serious uncontrolled cardiac arrhythmia) within 6 months before<br> randomization<br><br> - History or clinical evidence of symptomatic central nervous system (CNS) metastases<br><br> - Enrolled in any other clinical protocol or investigational trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events