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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Simcha IL-18, Inc.
Study ID
NCT04787042
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ST-067 — BIOLOGICAL
    ST-067 is an engineered variant of human interleukin-18.
  • Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] — BIOLOGICAL
    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.
  • pembrolizumab — BIOLOGICAL
    Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.

Study Details

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.

Key Dates

Start date
Aug 6, 2021
Status verified
Nov 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
316 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a, Dose Escalation
    In the Phase 1a monotherapy study, the starting dose of ST-067 will be 30 μg/kg, with a total of 7 dose level cohorts planned. The starting dose for the IV infusion monotherapy dosing will be 60 µg/kg. Patients will be treated every week with ST-067 in all cohorts. The DLT period is 28 days after the initial dose of ST-067. According to the mTPI schema initially there will be 3 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. Up to 12 patients will be treated at the RP2D.
  • Experimental: Phase 2, Expansion
    Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and microsatellite instability-high (MSI-Hi) tumors at the RP2D.
  • Experimental: Phase 1a, Dose Escalation, ST-067 SC + Obinutuzumab Pre-treatment
    Patients will be treated every week with ST-067 in all cohorts. The DLT period is 28 days after the initial dose of ST-067. According to the mTPI schema initially there will be 3 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. The starting dose for ST-067 with obinutuzumab pre-treatment will be 120µg/kg. Obinutuzumab will be administered at 1000 mg daily via IV infusion on 2 consecutive days, with the first dose given at least 7 days prior to first dose of SC ST-067.
  • Experimental: Phase 1 combination therapy
    Phase 1 dose escalation in combination with pembrolizumab will start at a dose of 30 µg/kg of ST-067 and 200 mg every 3 weeks of pembrolizumab. Patients will be treated every week with ST-067 and every three weeks with pembrolizumab. The MTD will be determined based on the mTPI design.

Primary Outcome Measure

Determine the maximum tolerated dose of ST-067 in phase 1a monotherapy [ Time Frame: Day 29 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Justin Moser, MD
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Gerald Falchook, MD, MS
Yale Cancer CenterNew HavenConnecticut06519
Harriet Kluger, MD
Moffitt Cancer CenterTampaFlorida33612
Ahmad Tarhini, MD
Massachusetts General HospitalBostonMassachusetts02114
Ryan Sullivan, MD
Roswell Park Cancer InstituteBuffaloNew York14263
Igor Puzanov, MD

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