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NCT04787042 · ClinicalTrials.gov registry record · Phase 1
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
A Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by Simcha IL-18.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 316
- Enrollment target
- 6
- Study locations
NCT04787042 is a Phase 1 study of Cancer and Non-Small Cell Lung Cancer that is actively recruiting participants, run by Simcha IL-18. The registered enrollment target is 316 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT04787042, a Phase 1 study of Cancer and Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Simcha IL-18.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 316 participants
- Enrollment target
- 6
- Study locations
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 Studied
Interventions
- BIOLOGICAL pembrolizumab
- BIOLOGICAL ST-067
- BIOLOGICAL Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]
Study Locations (6)
Arizona
- HonorHealth Research Institute - Scottsdale
Colorado
- Sarah Cannon Research Institute at HealthONE - Denver
Connecticut
- Yale Cancer Center - New Haven
Florida
- Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04787042
The ClinicalTrials.gov registry entry for NCT04787042 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Simcha IL-18, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which pembrolizumab is the first listed.
NCT04787042 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Arizona, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04787042 about?
NCT04787042 is a clinical study titled "Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067". 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...
What is the current status of trial NCT04787042?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 316 participants. The study started on 2021-08-06. Estimated completion is 2025-12-31.
What conditions does trial NCT04787042 study?
This clinical trial studies the following conditions: Cancer, Non-Small Cell Lung Cancer, Melanoma, Solid Tumor, Renal Cell Carcinoma.
What interventions are being tested in trial NCT04787042?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), ST-067 (BIOLOGICAL), Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] (BIOLOGICAL).
Who is sponsoring clinical trial NCT04787042?
This trial is sponsored by Simcha IL-18, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04787042 being conducted?
This trial has 6 study locations across Arizona, Colorado, Connecticut, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.