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
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
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.
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
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.
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.
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There are 19 Locations for this study
Tampa Florida, 33612, United States More Info
Merriam Kansas, 66204, United States
Louisville Kentucky, 40217, United States More Info
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