Study on the Safety and Effectiveness of ST-067 in Patients with Advanced Solid Tumors

Sponsor: Simcha IL-18, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT04787042

This clinical trial is testing a new treatment called ST-067 to see if it is safe and effective for patients with advanced solid tumors. The study will explore different ways of giving the treatment, either alone or with other medications, and will determine the best dose for future research.

Patient Parameters

Parameter	Options

Program Overview

This study is being conducted in multiple phases and locations to test a new treatment called ST-067 for patients with advanced solid tumors. In the first phase, researchers will find the safest dose of ST-067, given either by injection or with another drug called obinutuzumab, and in combination with pembrolizumab. The second phase will test how well ST-067 works on its own in treating different types of cancer, including melanoma, kidney cancer, and lung cancer, among others. The study will monitor patients' safety and how their tumors respond to the treatment.

Description

The study is divided into two main parts: Phase 1a and Phase 2.

In Phase 1a, the goal is to find the safest dose of ST-067 for patients with advanced solid tumors. This will involve giving the treatment by injection, either alone or with a pre-treatment using obinutuzumab, and in combination with pembrolizumab. Researchers will closely monitor patients for any side effects and determine the best dose to use in the next phase.

Phase 2 will focus on how well ST-067 works in treating specific types of cancer, such as melanoma, kidney cancer, and lung cancer. Patients will receive the treatment at the dose determined in Phase 1a, and researchers will assess how much the tumors shrink every 8-12 weeks. The study will also keep track of any side effects and overall safety throughout the trial.

Patients will be selected based on specific criteria, and their health will be monitored closely to ensure the treatment is safe and effective.

Eligibility Criteria

Inclusion Criteria

Adults aged 18 years or older.
Must agree to participate and sign a consent form.
Have a good overall health status, able to carry out normal activities.
Have a confirmed diagnosis of advanced or metastatic solid tumor.
For Phase 1a, eligible tumors include melanoma, kidney cancer, lung cancer, and others.
For Phase 2, eligible tumors include melanoma, kidney cancer, and lung cancer.
Have at least one tumor that can be measured and has not been treated with radiation.
Must be willing to provide a tumor sample for testing before and during treatment.

Exclusion Criteria

Have another type of cancer.
Have brain tumors that require high doses of steroids.
Have serious heart problems or recent heart attacks.
Have breathing difficulties.
Have active infections.
Have received a live vaccine recently.
Have had major surgery recently.
Have had organ or bone marrow transplants.
Have had high-dose chemotherapy.
Have active autoimmune diseases.
Are on immunosuppressive therapy.
Have had recent cancer treatments.
Have tested positive for COVID-19 recently.
Have adrenal gland problems.
Have abnormal blood test results.

Additional criteria for Phase 1 combination therapy:

Have active brain tumors or cancer in the brain lining.
Have had recent radiation therapy.
Have active autoimmune diseases requiring treatment.
Have had previous treatments with certain immune therapies and had severe reactions.
Have severe allergies to pembrolizumab.
Have lung diseases requiring steroids.
Have had recent high-dose lung radiation.

Locations

FACILITY	ZIP	CITY	STATE
HonorHealth Research Institute	85258	Scottsdale	Arizona
Sarah Cannon Research Institute at HealthONE	80218	Denver	Colorado
Yale Cancer Center	06519	New Haven	Connecticut
Moffitt Cancer Center	33612	Tampa	Florida
Massachusetts General Hospital	02114	Boston	Massachusetts
Roswell Park Cancer Institute	14263	Buffalo	New York

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