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

NCT05712356 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: LSTA1-P022023-503740-14
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

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

Keywords

immunotherapy; chemo; chemotherapy; first line; second line; progression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

LSTA1 arm for Untreated Cholangiocarcinoma

EXPERIMENTAL

Drug: certepetide; Drug: Durvalumab; Drug: Cisplatin; Drug: Gemcitabine

LSTA1 arm for Second-Line Cholangiocarcinoma

EXPERIMENTAL

Drug: certepetide; Drug: FOLFOX regimen

Placebo arm for Untreated Cholangiocarcinoma

PLACEBO COMPARATOR

Drug: Durvalumab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo

Placebo arm for Second-Line Cholangiocarcinoma

PLACEBO COMPARATOR

Drug: FOLFOX regimen; Drug: Placebo

Interventions

certepetide DRUG

LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given

Also known as: CEND-1, LSTA1

LSTA1 arm for Second-Line Cholangiocarcinoma; LSTA1 arm for Untreated Cholangiocarcinoma

Durvalumab DRUG

1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles

Also known as: Imfinzi

LSTA1 arm for Untreated Cholangiocarcinoma; Placebo arm for Untreated Cholangiocarcinoma

Cisplatin DRUG

cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

LSTA1 arm for Untreated Cholangiocarcinoma; Placebo arm for Untreated Cholangiocarcinoma

Gemcitabine DRUG

gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

LSTA1 arm for Untreated Cholangiocarcinoma; Placebo arm for Untreated Cholangiocarcinoma

FOLFOX regimen DRUG

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)

Also known as: Oxaliplatin, Folinic acid, Fluorouracil

LSTA1 arm for Second-Line Cholangiocarcinoma; Placebo arm for Second-Line Cholangiocarcinoma

Placebo DRUG

Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Placebo arm for Second-Line Cholangiocarcinoma; Placebo arm for Untreated Cholangiocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisata Therapeutics, Inc.: lead

Study Sites (19)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Alliance for Multispecialty Research

Merriam, Kansas, 66204, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202, United States

Location

Norton Cancer Institute, Audubon

Louisville, Kentucky, 40217, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Northwell Health - Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

FirstHealth of the Carolinas, Inc.

Pinehurst, North Carolina, 28374, United States

Location

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms; Disease Progression

Interventions

durvalumab; Cisplatin; Gemcitabine; Folfox protocol; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Bile Duct Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones

Study Officials

• Kristen K Buck, MD

  Lisata Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 3, 2023
• Study Start: August 24, 2023
• Primary Completion: April 18, 2026
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (19)