Clinical trial NCT05712356: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: Lisata Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 30 days after treatment discontinuation
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Merriam
country: United States
facility: Alliance for Multispecialty Research
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Downtown
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Audubon
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Lake Success
country: United States
facility: Northwell Health - Zuckerberg Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
affiliation: Lisata Therapeutics, Inc.
name: Kristen K Buck, MD
role: STUDY_CHAIR
References: