Bile Duct Cancer, Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Cancer, Gall Bladder Cancer, Gallbladder Carcinoma, Gall Bladder Carcinoma, Intrahepatic Cholangiocarcinoma
Conditions
Keywords
immunotherapy, chemo, chemotherapy, first line, second line, progression
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.
Interventions
DRUGcertepetide
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
DRUGDurvalumab
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
DRUGCisplatin
cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
DRUGGemcitabine
gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
DRUGFOLFOX regimen
The following will be given every 14 days: * oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion * fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes * fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
DRUGPlacebo
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Sponsors
Lisata Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Any Adverse Event | From time of consent until 30 days after treatment discontinuation, up to 18 months | 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 |
Countries
United States
Contacts
STUDY_CHAIRKristen K Buck, MD
Lisata Therapeutics, Inc.
Participant flow
Recruitment details
Subjects were enrolled from May 2023 to February 2025. All enrolled subjects were from sites in the United States.
Pre-assignment details
Subjects were screened for eligibility within 28 days prior to beginning the study run-in period. Subjects were required to meet all inclusion criteria and none of the exclusion criteria to be eligible for this trial. Screening information, including clinical evaluation, laboratory assessments, tumor biomarkers, imaging, archival tumor tissue if available, and pregnancy test for potential subjects were recorded in the electronic Case Report Form (eCRF), including reasons for ineligibility.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 9.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 23 | 4 / 11 | 10 / 21 | 2 / 11 |
| other Total, other adverse events | 23 / 23 | 11 / 11 | 20 / 21 | 11 / 11 |
| serious Total, serious adverse events | 10 / 23 | 3 / 11 | 12 / 21 | 4 / 11 |
Outcome results
None listed