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

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)

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 Overview

• Status: Terminated
• Conditions: Cholangiocarcinoma; Bile Duct Cancer; Intrahepatic Cholangiocarcinoma; Gallbladder Carcinoma; Gallbladder Cancer; Gall Bladder Cancer; Extrahepatic Cholangiocarcinoma; Gall Bladder Carcinoma
• Intervention / Treatment: Drug: Durvalumab; Drug: Placebo; Drug: Cisplatin; Drug: Gemcitabine; Drug: FOLFOX regimen; Drug: certepetide

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Kansas
    • Merriam, Kansas, United States, 66204
      • Alliance for Multispecialty Research
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute, Downtown
    • Louisville, Kentucky, United States, 40217
      • Norton Cancer Institute, Audubon
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health - Zuckerberg Cancer Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook Cancer Center
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LSTA1 arm for Untreated Cholangiocarcinoma	Drug: Durvalumab; 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles; Other Names: Imfinzi; 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: certepetide; LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given; Other Names: LSTA1; CEND-1
Experimental: LSTA1 arm for Second-Line Cholangiocarcinoma	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); Other Names: Folinic acid; Oxaliplatin; Fluorouracil; Drug: certepetide; LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given; Other Names: LSTA1; CEND-1
Placebo Comparator: Placebo arm for Untreated Cholangiocarcinoma	Drug: Durvalumab; 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles; Other Names: Imfinzi; Drug: Placebo; Placebo given as a slow IV push over 1 minute when standard treatment(s) are given; 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
Placebo Comparator: Placebo arm for Second-Line Cholangiocarcinoma	Drug: Placebo; Placebo given as a slow IV push over 1 minute when standard treatment(s) are given; 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); Other Names: Folinic acid; Oxaliplatin; Fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Experiencing Any Adverse Event	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	From time of consent until 30 days after treatment discontinuation, up to 18 months

Collaborators and Investigators

• Sponsor: Lisata Therapeutics, Inc.
• Investigators: Study Chair: Kristen K Buck, MD, Lisata Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Actual): April 5, 2026
• Study Completion (Actual): April 5, 2026

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; immunotherapy; first line; progression; second line; chemo
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Bile Duct Diseases; Gallbladder Diseases; Biliary Tract Neoplasms; Pathological Conditions, Signs and Symptoms; Disease Progression; Cholangiocarcinoma; Bile Duct Neoplasms; Gallbladder Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzymes and Coenzymes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Platinum Compounds; Oxaliplatin; Gemcitabine; Fluorouracil; Leucovorin; Cisplatin; durvalumab; Folfox protocol
• Other Study ID Numbers: LSTA1-P02; 2023-503740-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No