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

NCT04787042 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2024-11-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jeremy Barton, MD · Simcha IL-18, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787042 on ClinicalTrials.gov