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
Simcha IL-18, Inc.
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female patients aged ≥18 years 2. Must provide written informed consent and any authorizations required by local law 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lu…
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 InstituteScottsdale, Arizona
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Moffitt Cancer CenterTampa, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Roswell Park Cancer InstituteBuffalo, New York