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

Head and Neck Cancer 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

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 advanced head and neck squamous cell carcinoma and 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 advanced head and neck squamous cell carcinoma (HNSCC) and 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. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Head and Neck Squamous Cell Carcinoma
  • Bile Duct Cancer
  • Bile Duct Neoplasms
  • Cancer of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Cholangiocarcinoma
  • Extrahepatic Cholangiocarcinoma
  • Gall Bladder Cancer
  • Gall Bladder Carcinoma
  • Gallbladder Cancer
  • Gallbladder Carcinoma
  • Gallbladder Neoplasms
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Hypopharynx Cancer
  • Hypopharynx Squamous Cell Carcinoma
  • Intrahepatic Cholangiocarcinoma
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Larynx Cancer
  • Larynx Squamous Cell Carcinoma
  • Mouth Neoplasms
  • Oral Cavity Cancer
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Neoplasms
  • Oropharynx Cancer
  • Oropharynx Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma of the Hypopharynx
  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of the Oropharynx
  • Urinary Bladder Neoplasms
Clinical Trial Details
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
View Details
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