A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
- Conditions
- CholangiocarcinomaIntrahepatic CholangiocarcinomaGall Bladder CancerGallbladder CancerExtrahepatic CholangiocarcinomaBile Duct CancerGall Bladder CarcinomaGallbladder Carcinoma
- Interventions
- Registration Number
- NCT05712356
- Lead Sponsor
- Lisata Therapeutics, Inc.
- 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
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 67
-
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.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LSTA1 arm for Untreated Cholangiocarcinoma LSTA1 - LSTA1 arm for Untreated Cholangiocarcinoma Durvalumab - LSTA1 arm for Untreated Cholangiocarcinoma Cisplatin - LSTA1 arm for Untreated Cholangiocarcinoma Gemcitabine - LSTA1 arm for Second-Line Cholangiocarcinoma LSTA1 - LSTA1 arm for Second-Line Cholangiocarcinoma FOLFOX regimen - Placebo arm for Untreated Cholangiocarcinoma Durvalumab - Placebo arm for Untreated Cholangiocarcinoma Cisplatin - Placebo arm for Untreated Cholangiocarcinoma Gemcitabine - Placebo arm for Untreated Cholangiocarcinoma Placebo - Placebo arm for Second-Line Cholangiocarcinoma FOLFOX regimen - Placebo arm for Second-Line Cholangiocarcinoma Placebo -
- Primary Outcome Measures
Name Time Method Incidence of adverse events 30 days after treatment discontinuation 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
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