A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors — BOLSTER  

Cholangiocarcinoma Clinical Trial

Official title: A Phase 2a, Double-blind, Placebo-controlled, Multi-center, Randomized Study Evaluating LSTA1 When Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects With Advanced Solid Tumors (BOLSTER)

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Carcinoma
• Cholangiocarcinoma
• Extrahepatic Cholangiocarcinoma
• Gall Bladder Cancer
• Gall Bladder Carcinoma
• Gallbladder Cancer
• Gallbladder Carcinoma
• Gallbladder Neoplasms
• Intrahepatic Cholangiocarcinoma
• Urinary Bladder Neoplasms

• NCT number: NCT05712356
• Study type: Interventional
• Source: Lisata Therapeutics, Inc.
• Contact: Kathryn Shantz
• Phone: 484-437-6500
• Email: kshantz@lisata.com
• Status: Recruiting
• Phase: Phase 2
• Start date: August 24, 2023
• Completion date: December 2025