| 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 |
