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NCT03831295 · ClinicalTrials.gov registry record · Phase 1
SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by Ronald Levy.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03831295 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that has completed, run by Ronald Levy. The registered enrollment target is 12 participants, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03831295, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, has completed, sponsored by Ronald Levy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of intratumoral injection of SD-101 and BMS-986178 in treating patients with solid malignancies that have spread to other places in the body. The TLR9 agonist SD-101 may stimulate the immune system in different ways and stop cancer cells from growing. BMS-986178 is a monoclonal anti-OX40 antibody that enhances the activation of T cells, immune cells that are important for fighting tumors. Giving TLR9 agonist SD-101 together with anti-OX40 antibody BMS-986178 may work better in treating patients with advanced solid tumors.
Conditions Studied
Interventions
- BIOLOGICAL Anti-OX40 Antibody BMS 986178
- DRUG TLR9 Agonist SD-101
Study Locations (1)
California
- Stanford Cancer Institute Palo Alto - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2021-10-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03831295
The ClinicalTrials.gov registry entry for NCT03831295 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The listed sponsor is Ronald Levy, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Anti-OX40 Antibody BMS 986178 is the first listed.
NCT03831295 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03831295 about?
NCT03831295 is a clinical study titled "SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies". This phase I trial studies the side effects of intratumoral injection of SD-101 and BMS-986178 in treating patients with solid malignancies that have spread to other places in the body. The TLR9 agonist SD-101 may stimulate the immune system in different ways and stop cancer cells from growing. BMS-...
What is the current status of trial NCT03831295?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-03-13. Estimated completion is 2021-10-04.
What conditions does trial NCT03831295 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Extracranial Solid Neoplasm.
What interventions are being tested in trial NCT03831295?
The interventions under investigation include: Anti-OX40 Antibody BMS 986178 (BIOLOGICAL), TLR9 Agonist SD-101 (DRUG).
Who is sponsoring clinical trial NCT03831295?
This trial is sponsored by Ronald Levy, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03831295 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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