A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
← catalyst calendarSponsored by Lisata Therapeutics, Inc. (industry) · LSTA — their whole pipeline →.
Phase
Phase 2
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
66actual
Sites
19
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The study was halted prematurely to allow analysis of the results.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-05-13 | actual | When the study began enrolling |
| Primary completion | 2026-04-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-05 | actual | The whole study's end, after follow-up |
| First posted | 2023-02-03 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-26 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Cholangiocarcinoma
- Gallbladder Cancer
- Gallbladder Carcinoma
- Intrahepatic Cholangiocarcinoma
- Extrahepatic Cholangiocarcinoma
- Bile Duct Cancer
- Gall Bladder Cancer
- Gall Bladder Carcinoma
Interventions
- Drug: certepetide — also filed as CEND-1, LSTA1
- Drug: Durvalumab — also filed as Imfinzi
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: FOLFOX regimen — also filed as Oxaliplatin, Folinic acid, Fluorouracil
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFNumber of Subjects Experiencing Any Adverse Event
measured From time of consent until 30 days after treatment discontinuation, up to 18 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-07-16 · 19.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-09-25 · 16.1 MB · SAP_001.pdf
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