RecruitingPhase 1Phase 2NCT04787042

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies


Sponsor

Simcha IL-18, Inc.

Enrollment

316 participants

Start Date

Aug 6, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing ST-067, a new cancer immunotherapy drug. The study checks whether ST-067 is safe and shows signs of working in people with advanced solid tumors (cancers that form lumps in organs or tissues). The first phase focuses on safety; the second phase looks at effectiveness in specific cancer types. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of an advanced or metastatic solid tumor (such as melanoma, kidney cancer, lung cancer, bladder cancer, or others) - You are in reasonably good health overall (able to carry out daily activities) - You are willing to give informed consent **You may NOT be eligible if...** - Your cancer is not one of the approved tumor types for this trial - Your overall health status does not meet the study's fitness requirements - You have other conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALST-067

ST-067 is an engineered variant of human interleukin-18.

BIOLOGICALObinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]

Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B-cells.

BIOLOGICALpembrolizumab

Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.


Locations(6)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

View Full Details on ClinicalTrials.gov

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NCT04787042


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