NCT05712356

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Lisata Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	certepetide	LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
DRUG	Durvalumab	1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
DRUG	Cisplatin	cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
DRUG	Gemcitabine	gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
DRUG	FOLFOX regimen	The following will be given every 14 days: * oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion * fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes * fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
DRUG	Placebo	Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Timeline

• Start date: 2023-08-24
• Primary completion: 2026-04-18
• Completion: 2030-03-01
• First posted: 2023-02-03
• Last updated: 2025-06-06

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study