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LSTA1 + Standard Treatment for Pancreatic Cancer (FORTIFIDE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Lisata Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after treatment discontinuation

Summary

"This trial aims to test a new drug along with the usual treatment for metastatic pancreatic cancer. The trial will assess if the new drug is safe, well-tolerated, and more effective than the

Who is the study for?
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.
What is being tested?
The study is testing LSTA1 combined with standard chemo drugs Gemcitabine and Nab-paclitaxel against just the chemo drugs alone in patients with metastatic pancreatic ductal adenocarcinoma. It's checking if adding LSTA1 is safe, tolerable, and works better than current treatments.
What are the potential side effects?
Possible side effects include reactions related to infusion of the drug such as fever or chills; fatigue; nausea; hair loss due to chemotherapy; low blood counts leading to increased infection risk or bleeding problems; liver or kidney issues from drug toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer cannot be removed with surgery.
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My cancer progressed after first-line FOLFIRINOX treatment.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after treatment discontinuation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after treatment discontinuation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: SoC chemotherapy plus LSTA1 IV push and placebo infusionExperimental Treatment4 Interventions
Group II: SoC chemotherapy plus LSTA1 IV push and LSTA1 infusionExperimental Treatment3 Interventions
Group III: SoC chemotherapy plus Placebo IV push and placebo infusionActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Nab-paclitaxel
2014
Completed Phase 3
~1950

Find a Location

Who is running the clinical trial?

Lisata Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,342 Total Patients Enrolled
Kristen K. Buck, MDStudy ChairLisata Therapeutics, Inc.
~20 spots leftby Jun 2027
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