Trial Title:
LSTA1 Phase 1b/2a Continuous Infusion Trial in mPDAC
NCT ID:
NCT06592664
Condition:
Pancreas Cancer
Pancreatic Carcinoma
Pancreas Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Unresectable Pancreatic Cancer
Metastatic Pancreatic Cancer
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Conditions: Keywords:
Chemo
Chemotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
LSTA1
Description:
LSTA1 given as a slow IV push over 1 minute and as an IV infusion over 4 hours when
standard treatment(s) are given
Arm group label:
SoC chemotherapy plus LSTA1 IV push and LSTA1 infusion
Other name:
certepetide
Other name:
CEND-1
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
nab-paclitaxel 125 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days
Arm group label:
SoC chemotherapy plus LSTA1 IV push and LSTA1 infusion
Arm group label:
SoC chemotherapy plus LSTA1 IV push and placebo infusion
Arm group label:
SoC chemotherapy plus Placebo IV push and placebo infusion
Other name:
Abraxane
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
gemcitabine 1000 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days
Arm group label:
SoC chemotherapy plus LSTA1 IV push and LSTA1 infusion
Arm group label:
SoC chemotherapy plus LSTA1 IV push and placebo infusion
Arm group label:
SoC chemotherapy plus Placebo IV push and placebo infusion
Intervention type:
Drug
Intervention name:
Placebo matching LSTA1
Description:
Placebo given as a slow IV push over 1 minute and as an IV infusion over 4 hours when
standard treatment(s) are given
Arm group label:
SoC chemotherapy plus Placebo IV push and placebo infusion
Intervention type:
Drug
Intervention name:
LSTA1
Description:
LSTA1 given as a slow IV push over 1 minute when standard treatment(s) are given
Arm group label:
SoC chemotherapy plus LSTA1 IV push and placebo infusion
Other name:
certepetide
Other name:
CEND-1
Intervention type:
Drug
Intervention name:
Placebo matching LSTA1
Description:
Placebo given as an IV infusion over 4 hours when standard treatment(s) are given
Arm group label:
SoC chemotherapy plus LSTA1 IV push and placebo infusion
Summary:
The goal of this clinical trial is to test a new drug plus standard treatment compared
with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
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
Participants will:
- Visit the clinic three times every 28 days for treatment and tests
- Have CT or MRI scans every 8 weeks while on treatment
Detailed description:
This is a Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study
evaluating continuous infusion of LSTA1 over 4 hours when added to standard of care (SoC)
versus a single intravenous push of LSTA1 when added to SoC, versus SoC alone in people
with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed on
FOLFIRINOX.
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 three treatment groups.
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:
- Histologically or cytologically confirmed metastatic pancreatic ductal
adenocarcinoma that is considered unresectable
- Documented disease progression on first-line standard or modified FOLFIRINOX
treatment and be eligible for second-line treatment with nab-paclitaxel and
gemcitabine
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy ≥ 3 months
- At least one measurable tumor lesion as assessed by RECIST 1.1
- Adequate organ and marrow function
- Adequate contraception
Exclusion Criteria:
- Concurrent use of any other anti-cancer therapy including chemotherapy, targeted
therapy, immunotherapy, or biological agents
- Received prior anti-cancer therapy for their pancreatic cancer other than standard
or modified FOLFIRINOX
- Any condition or comorbidity that, in the opinion of the investigator, would
interfere with evaluation of study treatment or interpretation of subject 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
- Enrolled in any other clinical protocol or investigational trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85719
Country:
United States
Contact:
Last name:
Prisca Zimmerman
Phone:
520-626-8286
Email:
priscaz@arizona.edu
Investigator:
Last name:
Rachna Shroff, MD
Email:
Principal Investigator
Facility:
Name:
FirstHealth of the Carolinas, Inc.
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Contact:
Last name:
Lindsey Ferry
Phone:
910-715-2200
Email:
lferry@firsthealth.org
Investigator:
Last name:
Charles Kuzma, MD
Email:
Principal Investigator
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Contact:
Last name:
Stephanie Van Bebber
Phone:
571-472-4724
Email:
Stephanie.VanBebber@inova.org
Investigator:
Last name:
Raymond Wadlow, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
June 2027
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/NCT06592664
