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Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
NCT04787042 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Simcha IL-18, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04787042 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Arizona, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Melanoma, Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04787042?
This trial is sponsored by Simcha IL-18, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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