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

Sponsor

Lisata Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05712356

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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	Drug: LSTA1 Drug: Paclitaxel Drug: Docetaxel Drug: Durvalumab Drug: Cisplatin Drug: Gemcitabine Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LSTA1 arm for Advanced Head and Neck Squamous Cell Carcinoma	Drug: LSTA1 LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given Drug: Paclitaxel paclitaxel 175 mg/m^2 IV administered over 3 hours every 21 days
Experimental: LSTA1 arm for Esophageal Squamous Cell Carcinoma	Drug: LSTA1 LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given Drug: Docetaxel docetaxel 75 mg/m^2 IV administered over 1 hour every 21 days
Experimental: LSTA1 arm for Cholangiocarcinoma	Drug: LSTA1 LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given Drug: Durvalumab 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles Drug: 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 Drug: Gemcitabine gemcitabine 1000 mg/m^2 IV administered over 30 minutes on day 1 and day 8 every 21 days up to 8 cycles
Placebo Comparator: Placebo arm for Advanced Head and Neck Squamous Cell Carcinoma	Drug: Paclitaxel paclitaxel 175 mg/m^2 IV administered over 3 hours every 21 days Drug: Placebo Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Placebo Comparator: Placebo arm for Esophageal Squamous Cell Carcinoma	Drug: Docetaxel docetaxel 75 mg/m^2 IV administered over 1 hour every 21 days Drug: Placebo Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Placebo Comparator: Placebo arm for Cholangiocarcinoma	Drug: Durvalumab 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles Drug: 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 Drug: Gemcitabine gemcitabine 1000 mg/m^2 IV administered over 30 minutes on day 1 and day 8 every 21 days up to 8 cycles Drug: Placebo Placebo given as a slow IV push over 1 minute when standard treatment(s) are given

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [30 days after treatment discontinuation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 requiring systemic therapy
Known active hepatitis B virus, hepatitis C virus, or HIV infection
Active tuberculosis as defined per local guidance
Any other active infection (viral, fungal, or bacterial) requiring systemic therapy
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 chemotherapy, 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.