LSTA1 Phase 1b/2a Continuous Infusion Trial in mPDAC (FORTIFIDE)

Lisata Therapeutics

Status and phase: Begins enrollment in 2 months; Phase 2; Phase 1

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

Treatments: Drug: Placebo matching LSTA1; Drug: LSTA1; Drug: Nab-paclitaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06592664

LSTA1-P06

Details and patient eligibility

About

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

Full description

This is a Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study evaluating continuous infusion of LSTA1 over 4 hours when added to standard of care (SoC) versus a single intravenous push of LSTA1 when added to SoC, versus SoC alone in people with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed on FOLFIRINOX.

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that is considered unresectable
• Documented disease progression on first-line standard or modified FOLFIRINOX treatment and be eligible for second-line 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 criteria

• 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 other than standard or modified FOLFIRINOX

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

SoC chemotherapy plus LSTA1 IV push and LSTA1 infusion

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: LSTA1

Drug: LSTA1

SoC chemotherapy plus LSTA1 IV push and placebo infusion

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: LSTA1

Drug: Placebo matching LSTA1

Drug: Placebo matching LSTA1

Drug: LSTA1

SoC chemotherapy plus Placebo IV push and placebo infusion

Active Comparator group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Placebo matching LSTA1

Drug: Placebo matching LSTA1