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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: Completed Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by Ronald Levy.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome will be measured for any participant who has received at least one dose of any study medication. Treatment-limiting toxicities will be assessed using CTCAE v5.0. All adverse events will be recorded. Treatment-limiting toxicities are defined as; * Hematologic toxicities: Febrile neutropenia; Grade 3 \&4 thrombocytopenia; Grade 4 anemia unexplained with exception that toxicities can clearly be determined due to disease progression and/or unrelated to SD-101 or BMS-986178. * Non-hemat
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 |
What the finished NCT03831295 record still lists
NCT03831295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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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Where NCT03831295's enrollment target sits among peer trials
12 102nd of 108 higher than 7 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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