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

Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Phase 1a is designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ST067, administered by subcutaneous (SC) or intravenous (IV) dosing, in subjects with relapsed or refractory solid tumors, as well as to determine the MTD and recommended Phase 2 dose of ST067, administered SC with obinutuzumab (Gazyva®) as pretreatment in subjects with relapsed or refractory solid tumors using a modified toxicity probability interval (mTPI) design. There will be evaluations of ST-067 PK and PD effects. Phase 2 will evaluate the preliminary efficacy of ST-067 administered at the RP2D to patients with the following tumor types. A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts. RECIST 1.1 will be used to assess tumor response every 8-12 weeks. - Melanoma (n=28) - Renal cell carcinoma (n=25) - Triple-negative best cancer (n=25) - Non-small cell lung cancer (n=25) - squamous cell carcinoma of the head and neck (n=28) - MSI-Hi tumors (n=25) A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts. RECIST 1.1 will be used to assess tumor response every 8-12 weeks. Safety will be assessed for each patient throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04787042
Study type Interventional
Source Simcha IL-18, Inc.
Contact Beatrice McQueen, Ph.D.
Phone 805-300-3912
Email beatrice@simchatherapeutics.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 6, 2021
Completion date January 30, 2025
View Details
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