NCT04787042

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Simcha IL-18, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer
• Solid Tumor
• Melanoma
• Renal Cell Carcinoma
• Triple-negative Breast Cancer
• Non Small Cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck
• Carcinoma
• MSI-High

Interventions

Type	Name	Description
BIOLOGICAL	ST-067	ST-067 is an engineered variant of human interleukin-18.
BIOLOGICAL	Obinutuzumab 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.
BIOLOGICAL	pembrolizumab	Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.

Timeline

• Start date: 2021-08-06
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2021-03-08
• Last updated: 2024-11-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study