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

Cholangiocarcinoma Clinical Trial

— BOLSTER  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712356
• Other study ID #: LSTA1-P02
• Secondary ID: 2023-503740-14
• Status: Recruiting
• Phase: Phase 2
• Start date: August 24, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Lisata Therapeutics, Inc.
• Contact: Kathryn Shantz
• Phone: 484-437-6500
• Email: kshantz[@]lisata.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy = 3 months

• At least one measurable lesion as assessed by RECIST 1.1

• Adequate organ and marrow function

• Adequate contraception

• Patients with either of the following:

• Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible.

• Pathologically confirmed metastatic or unresectable cholangiocarcinoma or GBC with progression of disease after first-line chemotherapy and immunotherapy.

Exclusion Criteria:

• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:

• Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment

• Active infection (viral, fungal, or bacterial) requiring systemic therapy

• Known active hepatitis B virus, hepatitis C virus, or HIV infection

• Active tuberculosis as defined per local guidance

• History of allogeneic tissue/solid organ transplant

• Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

• Pregnant or breastfeeding

• Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization

• History or clinical evidence of symptomatic central nervous system (CNS) metastases

• For first-line cholangiocarcinoma, active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with Type 1 diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.

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

Intervention

Drug:
• LSTA1
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
• Durvalumab
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
• Cisplatin
cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
• Gemcitabine
gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
• FOLFOX regimen
The following will be given every 14 days: oxaliplatin 85 mg/m² and l-folinic acid 175 mg or d,l-folinic acid 350 mg 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)
• Placebo
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Locations

Country	Name	City	State
Spain	Hospital Universitario de Vinalopó	Elche	Alicante
Spain	Hospital Universitario de Jerez	Jerez De La Frontera	Cadiz
Spain	Hospital Universitario de Torrejón	Madrid
Spain	Start Madrid - Hospital Universitario HM Sanchinarro	Madrid
United States	Novant Health Cancer Institute	Charlotte	North Carolina
United States	Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Providence Medical Foundation	Fullerton	California
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Northwell Health - Zuckerberg Cancer Center	Lake Success	New York
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Norton Cancer Institute, Audubon	Louisville	Kentucky
United States	Norton Cancer Institute, Downtown	Louisville	Kentucky
United States	Alliance for Multispecialty Research	Merriam	Kansas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	FirstHealth of the Carolinas, Inc.	Pinehurst	North Carolina
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Novant Health Cancer Institute	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lisata Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study	30 days after treatment discontinuation