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COMPLETED Phase 1

SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies

NCT03831295 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 12 participants
Start Date 2019-03-13
Est. Completion 2021-10-04
Phase Phase 1

Sponsor

Ronald Levy

1 total trials

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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. 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 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ronald Levy, 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 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. 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: NCT03831295 reports 1 study location spanning 1 distinct geographic area — top geographies include California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03831295?

The interventions under investigation include: Anti-OX40 Antibody BMS 986178 (BIOLOGICAL), TLR9 Agonist SD-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03831295?

This trial is sponsored by Ronald Levy, 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 NCT03831295 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial