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

Primary Purpose

Esophageal Cancer, Head and Neck Squamous Cell Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LSTA1
Paclitaxel
Docetaxel
Durvalumab
Cisplatin
Gemcitabine
Placebo
Sponsored by
Lisata Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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). Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC. ESCC subjects have documented clinical or radiographic disease progression by RECIST 1.1 after first-line immunotherapy. 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. 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 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 Treatment in another interventional clinical study within the last 1 year History or clinical evidence of symptomatic central nervous system (CNS) metastases Has had prior targeted small molecule therapy, or radiation therapy for unresectable or metastatic HNSCC or ESCC 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.

Sites / Locations

  • Banner MD Anderson Cancer CenterRecruiting
  • University of Arizona Cancer CenterRecruiting
  • Alliance for Multispecialty Research
  • University of Kansas Cancer CenterRecruiting
  • University of Kentucky Medical CenterRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Stony Brook Cancer Center
  • Novant Health Cancer InstituteRecruiting
  • FirstHealth of the Carolinas, Inc.Recruiting
  • Novant Health Cancer InstituteRecruiting
  • Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer CenterRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Inova Schar Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

LSTA1 arm for Advanced Head and Neck Squamous Cell Carcinoma

LSTA1 arm for Esophageal Squamous Cell Carcinoma

LSTA1 arm for Cholangiocarcinoma

Placebo arm for Advanced Head and Neck Squamous Cell Carcinoma

Placebo arm for Esophageal Squamous Cell Carcinoma

Placebo arm for Cholangiocarcinoma

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events
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

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
October 11, 2023
Sponsor
Lisata Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05712356
Brief Title
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
Acronym
BOLSTER
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, esophageal 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
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 advanced head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Head and Neck Squamous Cell Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Cholangiocarcinoma, Esophageal Squamous Cell Carcinoma, Gallbladder Cancer, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LSTA1 arm for Advanced Head and Neck Squamous Cell Carcinoma
Arm Type
Experimental
Arm Title
LSTA1 arm for Esophageal Squamous Cell Carcinoma
Arm Type
Experimental
Arm Title
LSTA1 arm for Cholangiocarcinoma
Arm Type
Experimental
Arm Title
Placebo arm for Advanced Head and Neck Squamous Cell Carcinoma
Arm Type
Placebo Comparator
Arm Title
Placebo arm for Esophageal Squamous Cell Carcinoma
Arm Type
Placebo Comparator
Arm Title
Placebo arm for Cholangiocarcinoma
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LSTA1
Intervention Description
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
paclitaxel 175 mg/m^2 IV administered over 3 hours every 21 days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
docetaxel 75 mg/m^2 IV administered over 1 hour every 21 days
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
cisplatin 25 mg/m^2 IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
gemcitabine 1000 mg/m^2 IV administered over 30 minutes on day 1 and day 8 every 21 days up to 8 cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
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
Time Frame
30 days after treatment discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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). Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC. ESCC subjects have documented clinical or radiographic disease progression by RECIST 1.1 after first-line immunotherapy. 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. 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 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 Treatment in another interventional clinical study within the last 1 year History or clinical evidence of symptomatic central nervous system (CNS) metastases Has had prior targeted small molecule therapy, or radiation therapy for unresectable or metastatic HNSCC or ESCC 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Shantz
Phone
484-437-6500
Email
kshantz@lisata.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen K Buck, MD
Organizational Affiliation
Lisata Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madappa Kundranda, MD, PhD
Phone
480-256-6444
Email
Madappa.kundranda@bannerhealth.com
First Name & Middle Initial & Last Name & Degree
Madappa Kundranda, MD, PhD
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prisca Zimmerman
Email
priscaz@arizona.edu
First Name & Middle Initial & Last Name & Degree
Rachna Shroff, MD
Facility Name
Alliance for Multispecialty Research
City
Merriam
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Individual Site Status
Terminated
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Bradbury
Email
sbradbury@kumc.edu
First Name & Middle Initial & Last Name & Degree
Anup Kasi, MD, MPH
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Howard
Phone
859-323-8749
First Name & Middle Initial & Last Name & Degree
Susanne Arnold, MD
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Lovelace
Phone
702-952-3449
Email
ann.lovelace@usoncology.com
First Name & Middle Initial & Last Name & Degree
Gregory Obara, MD
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumbul Yousafi
Phone
631-638-0829
Email
Sumbul.Yousafi@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Roger Keresztes, MD
Facility Name
Novant Health Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demetria Jacks, MD
Email
dijacks@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Demetria Jacks, MD
Facility Name
FirstHealth of the Carolinas, Inc.
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie McBride
Phone
910-715-2200
Email
nmcbride@firsthealth.org
First Name & Middle Initial & Last Name & Degree
Charles Kuzma, MD
Facility Name
Novant Health Cancer Institute
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demetria Jacks, MD
Email
dijacks@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Demetria Jacks, MD
Facility Name
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Reed, RN
Phone
513-585-0844
First Name & Middle Initial & Last Name & Degree
Alexander Starodub, MD, PhD
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Hu, MD, PhD
Email
GIClinicalTrials@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ian Hu, MD, PhD
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Van Bebber
Phone
571-472-4724
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Raymond Wadlow, MD

12. IPD Sharing Statement

Learn more about this trial

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

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