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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Bile Duct Cancer, Gall Bladder Cancer, Gall Bladder Carcinoma

In brief

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

Key facts

Study ID

NCT05712356

Run by

Lisata Therapeutics, Inc.

People needed

66

Starts

2023-05-13

Expected to finish

2026-04-05

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Alliance for Multispecialty Research — Merriam, Kansas, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Norton Cancer Institute, Downtown — Louisville, Kentucky, United States
• Norton Cancer Institute, Audubon — Louisville, Kentucky, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Northwell Health - Zuckerberg Cancer Center — Lake Success, New York, United States
• Stony Brook Cancer Center — Stony Brook, New York, United States
• FirstHealth of the Carolinas, Inc. — Pinehurst, 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
• Spartanburg Medical Center — Spartanburg, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.