The goal of this clinical trial is to test a new drug plus standard treatment compared
with standard treatment alone in patients with previously untreated cholangiocarcinoma or
those that have progressed after first-line treatment for cholangiocarcinoma.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05712356.
This is a Phase 2a, double-blind, placebo-controlled, multi-center, randomized study of
LSTA1 when added to standard of care (SoC) versus SoC alone in patients with advanced
solid tumors. The study will include patients with previously untreated
cholangiocarcinoma or those that have progressed after first-line treatment for
cholangiocarcinoma.
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 two treatment groups (SoC + placebo vs. SoC
+ LSTA1).
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.
Lead OrganizationLisata Therapeutics, Inc.
Principal InvestigatorKristen K. Buck
