Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05712356




Registration number
NCT05712356
Ethics application status
Date submitted
26/01/2023
Date registered
3/02/2023
Date last updated
18/03/2024

Titles & IDs
Public title
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2023-503740-14
Secondary ID [2] 0 0
LSTA1-P02
Universal Trial Number (UTN)
Trial acronym
BOLSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Advanced Head and Neck Squamous Cell Carcinoma 0 0
Head and Neck Cancer 0 0
Cholangiocarcinoma 0 0
Gallbladder Cancer 0 0
Gallbladder Carcinoma 0 0
Intrahepatic Cholangiocarcinoma 0 0
Extrahepatic Cholangiocarcinoma 0 0
Bile Duct Cancer 0 0
Cancer of the Head and Neck 0 0
HNSCC 0 0
Oropharynx Cancer 0 0
Oral Cavity Cancer 0 0
Hypopharynx Cancer 0 0
Larynx Cancer 0 0
Oral Cavity Squamous Cell Carcinoma 0 0
Squamous Cell Carcinoma of Head and Neck 0 0
Squamous Cell Carcinoma of the Head and Neck 0 0
Squamous Cell Carcinoma of the Larynx 0 0
Squamous Cell Carcinoma of the Hypopharynx 0 0
Squamous Cell Carcinoma of the Oral Cavity 0 0
Squamous Cell Carcinoma of the Oropharynx 0 0
Gall Bladder Cancer 0 0
Gall Bladder Carcinoma 0 0
Oropharynx Squamous Cell Carcinoma 0 0
Hypopharynx Squamous Cell Carcinoma 0 0
Larynx Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LSTA1
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Durvalumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Placebo

Experimental: LSTA1 arm for Advanced Head and Neck Squamous Cell Carcinoma -

Experimental: LSTA1 arm for Cholangiocarcinoma -

Placebo Comparator: Placebo arm for Advanced Head and Neck Squamous Cell Carcinoma -

Placebo Comparator: Placebo arm for Cholangiocarcinoma -


Treatment: Drugs: LSTA1
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given

Treatment: Drugs: Paclitaxel
paclitaxel 175 mg/m^2 IV administered over 3 hours every 21 days

Treatment: Drugs: Durvalumab
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles

Treatment: Drugs: Cisplatin
cisplatin 25 mg/m^2 IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles

Treatment: Drugs: Gemcitabine
gemcitabine 1000 mg/m^2 IV administered over 30 minutes on day 1 and day 8 every 21 days up to 8 cycles

Treatment: Drugs: Placebo
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
30 days after treatment discontinuation

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy = 3 months

- At least one measurable metastatic lesion as assessed by RECIST 1.1

- Adequate organ and marrow function

- Adequate contraception

- Patients with any of the following:

- Histologically confirmed recurrent or metastatic HNSCC that is unresectable or
considered incurable by local therapies and that has progressed after first-line
immunotherapy. The eligible primary tumor locations are oropharynx, oral cavity,
hypopharynx, and larynx. Patients may not have primary tumor sites of the skin,
paranasal sinuses, or the nasopharynx (any histology).

- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- Has known allergies to taxanes or their standard pretreatments for unresectable or
metastatic HNSCC

- For 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Spain
State/province [15] 0 0
Alicante
Country [16] 0 0
Spain
State/province [16] 0 0
Cadiz
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lisata Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 advanced head and neck squamous cell carcinoma and
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05712356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristen K Buck, MD
Address 0 0
Lisata Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathryn Shantz
Address 0 0
Country 0 0
Phone 0 0
484-437-6500
Fax 0 0
Email 0 0
kshantz@lisata.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05712356