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

NCT05712356

Additional Institutions

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 For the current site list and contact information, please see https://clinicaltrials.gov/ct2/show/NCT05712356

Principal Investigator

Multiple Investigators

Additional Principal Investigators

For the current site list and contact information, please see https://clinicaltrials.gov/ct2/show/NCT05712356

Study Coordinator

Multiple Coordinators

Additional Study Coordinators

For the current site list and contact information, please see https://clinicaltrials.gov/ct2/show/NCT05712356

Study Overview

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 Information

120 patients total, 40 for cholangiocarcinoma

Study Start Date

20230601

Study End Date

20251231

Study Purpose

Is the new drug plus standard treatment safe and tolerable Is the new drug plus standard treatment more effective than standard treatment

Inclusion Criteria

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

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 Study

History and Physical Exam CT or MRI ECG Blood work

Financial Assistance Available

No

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