Study on Continuous Infusion of LSTA1 with Standard Treatment for Metastatic Pancreatic Cancer

Sponsor: Lisata Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06592664

Provider View

This clinical trial is testing a new drug, LSTA1, combined with standard treatment to see if it is safe and more effective than the standard treatment alone for people with metastatic pancreatic cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding a new drug, LSTA1, to the usual treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) is safe and works better than the usual treatment by itself. Participants will visit the clinic three times every 28 days for treatment and tests, and will have CT or MRI scans every 8 weeks while on treatment.

Description

This study is in two phases, Phase 1b and Phase 2a, and is designed to test the safety and effectiveness of a new drug, LSTA1, when given continuously over 4 hours, compared to a single quick dose, or the standard treatment alone, in people with metastatic pancreatic cancer that has worsened after FOLFIRINOX treatment.

The study includes several parts: a screening period to check eligibility, a short run-in period to start the treatment, a treatment period, a visit after treatment ends, and a long-term follow-up period.

Participants who agree to join the study will be checked for eligibility within 28 days before starting the treatment. Once confirmed, they will be randomly assigned to one of three groups: one receiving continuous LSTA1, one receiving a single dose of LSTA1, or one receiving the standard treatment alone.

During the initial 3-day run-in period, participants will receive only the LSTA1 or a placebo. After this, the first cycle of treatment will begin. Tumor scans will be done every 8 weeks to monitor progress.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic pancreatic ductal adenocarcinoma that cannot be removed by surgery.
  • The cancer must have worsened after first-line treatment with FOLFIRINOX and be eligible for second-line treatment with nab-paclitaxel and gemcitabine.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Have at least one tumor that can be measured by scans.
  • Have good organ and bone marrow function.
  • Agree to use effective contraception during the study.

Exclusion Criteria

  • Currently using any other cancer treatments, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
  • Have received any other cancer treatment for pancreatic cancer besides FOLFIRINOX.
  • Have any condition that could interfere with the study or affect safety, such as:
    • Major surgery or radiation therapy less than 4 weeks before starting the study.
    • Active infections requiring treatment.
    • Active hepatitis B, hepatitis C, or HIV infection.
    • Active tuberculosis.
    • History of organ transplant.
    • Other cancers requiring treatment in the past 3 years, except for certain skin cancers or localized cancers that have been cured.
    • Pregnant or breastfeeding.
    • Serious heart or blood vessel problems within 6 months before starting the study.
  • Have cancer that has spread to the brain causing symptoms.
  • Participating in another clinical trial.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.