Trial Title:
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients with Advanced Solid Tumors
NCT ID:
NCT05712356
Condition:
Cholangiocarcinoma
Gallbladder Cancer
Gallbladder Carcinoma
Intrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
Bile Duct Cancer
Gall Bladder Cancer
Gall Bladder Carcinoma
Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Gemcitabine
Oxaliplatin
Fluorouracil
Durvalumab
Conditions: Keywords:
immunotherapy
chemo
chemotherapy
first line
second line
progression
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
LSTA1
Description:
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are
given
Arm group label:
LSTA1 arm for Second-Line Cholangiocarcinoma
Arm group label:
LSTA1 arm for Untreated Cholangiocarcinoma
Other name:
certepetide
Other name:
CEND-1
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every
28 days for additional cycles
Arm group label:
LSTA1 arm for Untreated Cholangiocarcinoma
Arm group label:
Placebo arm for Untreated Cholangiocarcinoma
Other name:
Imfinzi
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for
up to 8 cycles
Arm group label:
LSTA1 arm for Untreated Cholangiocarcinoma
Arm group label:
Placebo arm for Untreated Cholangiocarcinoma
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days
for up to 8 cycles
Arm group label:
LSTA1 arm for Untreated Cholangiocarcinoma
Arm group label:
Placebo arm for Untreated Cholangiocarcinoma
Intervention type:
Drug
Intervention name:
FOLFOX regimen
Description:
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)
Arm group label:
LSTA1 arm for Second-Line Cholangiocarcinoma
Arm group label:
Placebo arm for Second-Line Cholangiocarcinoma
Other name:
Oxaliplatin
Other name:
Folinic acid
Other name:
Fluorouracil
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Arm group label:
Placebo arm for Second-Line Cholangiocarcinoma
Arm group label:
Placebo arm for Untreated Cholangiocarcinoma
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.
Criteria for eligibility:
Criteria:
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
- For first-line cholangiocarcinoma, active autoimmune disease that might deteriorate
when receiving an immune-stimulatory agent. Patients with Type 1 diabetes, vitiligo,
psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive
treatment are eligible.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Madappa Kundranda, MD, PhD
Phone:
480-256-6444
Email:
Madappa.kundranda@bannerhealth.com
Contact backup:
Last name:
Madappa Kundranda, MD, PhD
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Contact backup:
Last name:
Bassam Sonbol, MD
Facility:
Name:
University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prisca Zimmerman
Email:
priscaz@arizona.edu
Contact backup:
Last name:
Rachna Shroff, MD
Facility:
Name:
Providence Medical Foundation
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Withdrawn
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taylor Atkinson
Contact backup:
Phone:
813-745-6851
Email:
Taylor.Atkinson@moffitt.org
Contact backup:
Last name:
Richard Kim, MD
Facility:
Name:
Alliance for Multispecialty Research
Address:
City:
Merriam
Zip:
66204
Country:
United States
Status:
Terminated
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University of Kentucky Medical Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Norton Cancer Institute, Downtown
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Email:
MISC-NCIResearch@nortonhealthcare.org
Contact backup:
Last name:
Michael Driscoll, MD
Facility:
Name:
Norton Cancer Institute, Audubon
Address:
City:
Louisville
Zip:
40217
Country:
United States
Status:
Recruiting
Contact:
Email:
MISC-NCIResearch@nortonhealthcare.org
Contact backup:
Last name:
Michael Driscoll, MD
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Contact backup:
Last name:
Nguyen Tran, MD
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Withdrawn
Facility:
Name:
Northwell Health - Zuckerberg Cancer Center
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Terminated
Facility:
Name:
Stony Brook Cancer Center
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Terminated
Facility:
Name:
Novant Health Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Withdrawn
Facility:
Name:
FirstHealth of the Carolinas, Inc.
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lindsey Ferry
Phone:
910-715-2200
Email:
lferry@firsthealth.org
Contact backup:
Last name:
Charles Kuzma, MD
Facility:
Name:
Novant Health Cancer Institute
Address:
City:
Winston-Salem
Zip:
27103
Country:
United States
Status:
Withdrawn
Facility:
Name:
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abby Reed, RN
Phone:
513-585-0844
Contact backup:
Last name:
Alexander Starodub, MD, PhD
Facility:
Name:
Spartanburg Medical Center
Address:
City:
Spartanburg
Zip:
29303
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristen Ford
Phone:
8645306554
Email:
kford@gibbscc.org
Contact backup:
Last name:
Vikas Dembla, MD
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ian Hu, MD, PhD
Email:
GIClinicalTrials@mdanderson.org
Contact backup:
Last name:
Ian Hu, MD, PhD
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephanie Van Bebber
Phone:
571-472-4724
Email:
Stephanie.VanBebber@inova.org
Contact backup:
Last name:
Raymond Wadlow, MD
Facility:
Name:
Hospital Universitario de Vinalopó
Address:
City:
Elche
Zip:
03293
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital Universitario de Jerez
Address:
City:
Jerez De La Frontera
Zip:
11407
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Start Madrid - Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital Universitario de Torrejón
Address:
City:
Madrid
Zip:
28850
Country:
Spain
Status:
Withdrawn
Start date:
August 24, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Lisata Therapeutics, Inc.
Agency class:
Industry
Source:
Lisata Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712356
