CholangiocarcinomaPhase 2BOLSTERNCT05712356
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
A Phase 2 study testing certepetide, Durvalumab and Cisplatin in people with Cholangiocarcinoma and Gallbladder Cancer, run by Lisata Therapeutics, Inc. at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma
- What is being tested?
- certepetide, Durvalumab and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 19 sitesUnited States
- Study dates
- 13 May 2023to 5 Apr 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Northwell Health - Zuckerberg Cancer Center
Lake Success, New York, 11042
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
Norton Cancer Institute, Audubon
Louisville, Kentucky, 40217
Alliance for Multispecialty Research
Merriam, Kansas, 66204
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic Arizona
Phoenix, Arizona, 85054
FirstHealth of the Carolinas, Inc.
Pinehurst, North Carolina, 28374
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Stony Brook Cancer Center
Stony Brook, New York, 11794
Moffitt Cancer Center
Tampa, Florida, 33612
University of Arizona Cancer Center
Tucson, Arizona, 85719
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
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)
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
Read the 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.
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
- Being tested
- certepetide, Durvalumab, Cisplatin, Gemcitabine, FOLFOX regimen
- Keywords
- immunotherapy, chemo, chemotherapy, first line, second line, progression
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms, Bile Duct Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
certepetideDrug
Also called CEND-1, LSTA1
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
DurvalumabDrug
Also called Imfinzi
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
CisplatinDrug
cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
GemcitabineDrug
gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
FOLFOX regimenDrug
Also called Oxaliplatin, Folinic acid, Fluorouracil
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)
PlaceboDrug
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
| Study group | Role | What they receive |
|---|---|---|
| LSTA1 arm for Untreated Cholangiocarcinoma | Experimental | Not described Receives: Drug: certepetide; Drug: Durvalumab; Drug: Cisplatin; Drug: Gemcitabine |
| LSTA1 arm for Second-Line Cholangiocarcinoma | Experimental | Not described Receives: Drug: certepetide; Drug: FOLFOX regimen |
| Placebo arm for Untreated Cholangiocarcinoma | Placebo comparator | Not described Receives: Drug: Durvalumab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo |
| Placebo arm for Second-Line Cholangiocarcinoma | Placebo comparator | Not described Receives: Drug: FOLFOX regimen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Any Adverse Event
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
Measured: From time of consent until 30 days after treatment discontinuation, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start13 May 2023
- Primary completion5 Apr 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristen K Buck, MD, Study chair, Lisata Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712356
- Sponsor's protocol ID
- LSTA1-P02
- Other IDs
- 2023-503740-14, 2023
- Acronym
- BOLSTER
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2023
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No