Esophageal Cancer Clinical Trial

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

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

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT05712356

Recruitment Status:

Recruiting

Sponsor:

Lisata Therapeutics, Inc.

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There are 27 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Madappa Kundranda, MD, PhD
Contact
480-256-6444
[email protected]
Madappa Kundranda, MD, PhD
Principal Investigator
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
Bassam Sonbol, MD
Principal Investigator
University of Arizona Cancer Center
Tucson Arizona, 85719, United States More Info
Prisca Zimmerman
Contact
[email protected]
Rachna Shroff, MD
Principal Investigator
Providence Medical Foundation
Fullerton California, 92835, United States More Info
Linda Gozar
Contact
714-992-3000
[email protected]
David Park, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Taylor Atkinson
Contact
Richard Kim, MD
Principal Investigator
Alliance for Multispecialty Research
Merriam Kansas, 66204, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States More Info
Shannon Bradbury
Contact
[email protected]
Anup Kasi, MD, MPH
Principal Investigator
University of Kentucky Medical Center
Lexington Kentucky, 40536, United States More Info
Sarah Howard
Contact
859-323-8749
Susanne Arnold, MD
Principal Investigator
Norton Cancer Institute, Downtown
Louisville Kentucky, 40202, United States More Info
Michael Driscoll, MD
Principal Investigator
Norton Cancer Institute, Audubon
Louisville Kentucky, 40217, United States More Info
Michael Driscoll, MD
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
Nguyen Tran, MD
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Northwell Health - Zuckerberg Cancer Center
Lake Success New York, 11042, United States More Info
Jenna Battaglia
Contact
516-734-8812
[email protected]
Anna Levy, DO
Principal Investigator
Stony Brook Cancer Center
Stony Brook New York, 11794, United States More Info
Sumbul Yousafi
Contact
631-638-0829
[email protected]
Roger Keresztes, MD
Principal Investigator
Novant Health Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Demetria Jacks, MD
Contact
[email protected]
Demetria Jacks, MD
Principal Investigator
FirstHealth of the Carolinas, Inc.
Pinehurst North Carolina, 28374, United States More Info
Lindsey Ferry
Contact
910-715-2200
[email protected]
Charles Kuzma, MD
Principal Investigator
Novant Health Cancer Institute
Winston-Salem North Carolina, 27103, United States More Info
Demetria Jacks, MD
Contact
[email protected]
Demetria Jacks, MD
Principal Investigator
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati Ohio, 45219, United States More Info
Abby Reed, RN
Contact
513-585-0844
Alexander Starodub, MD, PhD
Principal Investigator
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States More Info
Kristen Ford
Contact
864-530-6554
[email protected]
Vikas Dembla, MD
Principal Investigator
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
VUMC Patient Recruitment Office
Contact
800-811-8480
[email protected]
Thatcher Heumann, MD
Principal Investigator
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Ellen Siglinsky
Contact
214-645-9684
[email protected]
David Hsieh, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ian Hu, MD, PhD
Contact
[email protected]
Ian Hu, MD, PhD
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Stephanie Van Bebber
Contact
571-472-4724
[email protected]
Raymond Wadlow, MD
Principal Investigator
Hospital Universitario de Vinalopó
Elche Alicante, 03293, Spain
Hospital Universitario de Jerez
Jerez De La Frontera Cadiz, 11407, Spain
Start Madrid - Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario de Torrejón
Madrid , 28850, Spain

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT05712356

Recruitment Status:

Recruiting

Sponsor:


Lisata Therapeutics, Inc.

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