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NCT04064359 · ClinicalTrials.gov registry record · Phase 1
Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Oxford BioTherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT04064359: Recruiting Phase 1 study of Solid Tumor, sponsored by Oxford BioTherapeutics.
NCT04064359 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Oxford BioTherapeutics. The registered enrollment target is 200 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04064359, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Oxford BioTherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.
Primary Outcome
Assess incidence of all AEs by NCI CTCAE (Version 5) grades 1-5
Conditions Studied
Interventions
- DRUG OBT076, a CD205-directed antibody-drug conjugate
Study Locations (20)
Other
- Institut Jules Bordet - Brussels
- AZ Groeninge - Kortrijk
- Institut Paoli Calmettes - Marseille
- GHP Saint-Joseph - Paris
- Hopital Saint Antoine - Paris
- Hopital Saint Louis - Paris
- Centre Eugène Marquis - Rennes
- ICANS - Institut de cancérologie Strasbourg - Strasbourg
- Institut Gustave Roussy - IGR - Villejuif
California
- Cedars-Sinai - Los Angeles
- UCLA - Santa Monica
Arizona
- Mayo Clinic - Phoenix
Florida
- Moffitt Cancer Center - Tampa
Iowa
- The State University of Iowa - Iowa City
Kentucky
- St. Elizabeth Healthcare - Edgewood
Mississippi
- University of Mississippi Medical Center - Jackson
New Mexico
- Quantum Santa Fe - Santa Fe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04064359 shows while recruiting
NCT04064359 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which OBT076, a CD205-directed antibody-drug conjugate is the first listed.
NCT04064359 names 20 study sites across 11 states, led by Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04064359 about?
NCT04064359 is a clinical study titled "Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors". The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to targe...
What is the current status of trial NCT04064359?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2019-07-25. Estimated completion is 2027-12-31.
What conditions does trial NCT04064359 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT04064359?
The interventions under investigation include: OBT076, a CD205-directed antibody-drug conjugate (DRUG).
Who is sponsoring clinical trial NCT04064359?
This trial is sponsored by Oxford BioTherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04064359 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04064359's enrollment target sits among peer trials
200 38th of 196 higher than 157 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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