A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Lisata Therapeutics, Inc.
Study ID
NCT05712356
Phase
PHASE2
Status
Terminated

Conditions

  • Bile Duct Cancer
  • Cholangiocarcinoma
  • Extrahepatic Cholangiocarcinoma
  • Gall Bladder Cancer
  • Gall Bladder Carcinoma
  • Gallbladder Cancer
  • Gallbladder Carcinoma
  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • certepetide — DRUG
    LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
  • Durvalumab — DRUG
    1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
  • Cisplatin — DRUG
    cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
  • Gemcitabine — DRUG
    gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
  • FOLFOX regimen — DRUG
    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)
  • Placebo — DRUG
    Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Study Details

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

Key Dates

Start date
May 13, 2023
Status verified
Apr 2026
Primary completion
Apr 5, 2026
Completion
Apr 5, 2026

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LSTA1 arm for Untreated Cholangiocarcinoma
  • Experimental: LSTA1 arm for Second-Line Cholangiocarcinoma
  • Placebo Comparator: Placebo arm for Untreated Cholangiocarcinoma
  • Placebo Comparator: Placebo arm for Second-Line Cholangiocarcinoma

Primary Outcome Measure

Number of Subjects Experiencing Any Adverse Event [ Time Frame: From time of consent until 30 days after treatment discontinuation, up to 18 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo Clinic ArizonaPhoenixArizona85054-
University of Arizona Cancer CenterTucsonArizona85719-
Moffitt Cancer CenterTampaFlorida33612-
Alliance for Multispecialty ResearchMerriamKansas66204-
University of Kansas Cancer CenterWestwoodKansas66205-
University of Kentucky Medical CenterLexingtonKentucky40536-
Norton Cancer Institute, AudubonLouisvilleKentucky40217-
Norton Cancer Institute, DowntownLouisvilleKentucky40202-
Mayo Clinic RochesterRochesterMinnesota55905-
Northwell Health - Zuckerberg Cancer CenterLake SuccessNew York11042-
Stony Brook Cancer CenterStony BrookNew York11794-
FirstHealth of the Carolinas, Inc.PinehurstNorth Carolina28374-
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer CenterCincinnatiOhio45219-
Spartanburg Medical CenterSpartanburgSouth Carolina29303-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75390-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZMayo Clinic Arizona· Phoenix, AZUniversity of Arizona Cancer Center· Tucson, AZMoffitt Cancer Center· Tampa, FLAlliance for Multispecialty Research· Merriam, KSUniversity of Kansas Cancer Center· Westwood, KS

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