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)

June 14, 2023

Study Name
	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)
ClinicalTrials.gov Identifier (if applicable)
	NCT05712356
Clinical Trial Category (check all that apply)
	First Line Therapy Chemotherapy Immunotherapy Other Novel Therapy
Study Center
Institution Name
	Arizona: Banner MD Anderson Cancer Center Kansas: University of Kansas Cancer Center Kentucky: University of Kentucky Medical Center Nevada: Comprehensive Cancer Centers of Nevada Ohio: Christ Hospital Cancer Center Texas: University of Texas MD Anderson Cancer Center Virginia: Inova Schar Cancer Institute
List additional Institutions (include address, phone number, and website)
	For the current site list and contact information, please see https://clinicaltrials.gov/ct2/show/NCT05712356
Study Contacts
Principal Investigator
	Multiple Investigators
P.I. Phone
	(000) 000-0000
P.I. Email
	TBD@TBD.com
List additional Principal Investigators (include phone number and email)
	For the current site list and contact information, please see https://clinicaltrials.gov/ct2/show/NCT05712356
Study Coordinator
	Multiple Coordinators
Study Coordinator Phone
	(000) 000-0000
Study Coordinator Email
	TBD@TBD.com
List additional Study Coordinators (include phone number and email)
	For the current site list and contact information, please see https://clinicaltrials.gov/ct2/show/NCT05712356
OVERVIEW – in layman’s terms (150 words max)
	This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.
Enrollment
	120 patients total, 40 for cholangiocarcinoma
Study Start Date
	06/01/2023
Estimated Completion Date
	12/31/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Is the new drug plus standard treatment safe and tolerable Is the new drug plus standard treatment more effective than standard treatment
Inclusion Criteria – Patients Must:
	Previously untreated metastatic or unresectable cholangiocarcinoma or gallbladder cancer Measurable disease per RECIST v1.1 ECOG performance status 0 or 1 Adequate organ and bone marrow function Adequate contraception
Exclusion Criteria – Patients Must NOT:
	Any major surgery 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 History of allogeneic tissue/solid organ transplant Prior malignancy requiring active treatment within the previous 3 years Significant or symptomatic cardiovascular/cerebrovascular disease (e.g., heart attack, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months History or clinical evidence of symptomatic central nervous system (CNS) metastases Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent Pregnant or breastfeeding
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	History and Physical Exam CT or MRI ECG Blood work