LSTA1 + Standard Treatment for Pancreatic Cancer
(FORTIFIDE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you do not use any other anti-cancer therapy while participating. However, it does not specify about other types of medications, so you should discuss your current medications with the trial team.
What data supports the effectiveness of the treatment LSTA1 for pancreatic cancer?
Research shows that CEND-1, a component of LSTA1, helps drugs reach tumors more effectively by improving their delivery and penetration into tumor tissues. This has been demonstrated in pre-clinical models and suggests that LSTA1 could enhance the effectiveness of standard treatments for pancreatic cancer by improving drug access to the tumor.12345
Is LSTA1 (CEND-1) safe for humans?
What makes the drug LSTA1 unique for treating pancreatic cancer?
LSTA1 (also known as iRGD) is unique because it helps drugs penetrate the dense tissue surrounding pancreatic tumors, which is a major barrier in treating this cancer. By targeting specific proteins on tumor cells, it enhances the delivery of therapeutic agents directly to the cancer cells, potentially improving treatment effectiveness.34101112
What is the purpose of this trial?
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 treatmentParticipants will:* Visit the clinic three times every 28 days for treatment and tests* Have CT or MRI scans every 8 weeks while on treatment
Research Team
Kristen K. Buck, MD
Principal Investigator
Lisata Therapeutics, Inc.
Eligibility Criteria
This trial is for adults with advanced pancreatic cancer that has spread and can't be surgically removed. They should have a certain level of fitness (able to carry out light activities), expect to live at least 3 more months, have tumors measurable by scans, proper organ function, and must use birth control. Only those who've had specific first-line chemotherapy but the cancer got worse can join.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants receive LSTA1 or placebo components of their randomized treatment regimen
Treatment
Participants receive the study treatment with LSTA1 or placebo added to standard of care
End-of-treatment Follow-up
Participants have an end-of-treatment follow-up visit
Long-term Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LSTA1
LSTA1 is already approved in United States, European Union for the following indications:
- Orphan drug designation for malignant glioma
- Orphan drug designation for osteosarcoma
- Fast track designation for pancreatic cancer
- Orphan drug designation for pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lisata Therapeutics, Inc.
Lead Sponsor