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NCT05865535 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
A Phase 1 study of Cachexia, sponsored by AVEO Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 12
- Study locations
NCT05865535 is a Phase 1 study of Cachexia that is actively recruiting participants, run by AVEO Pharmaceuticals. The registered enrollment target is 30 participants, below the 200-participant average among 13 other Cachexia trials with a reported enrollment target (85% lower). The trial reports 12 study locations across 10 states.
The verdict
NCT05865535, a Phase 1 study of Cachexia, is actively recruiting participants, sponsored by AVEO Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 12
- Study locations
Study Summary
This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
Conditions Studied
Interventions
- BIOLOGICAL AV-380
Study Locations (12)
California
- Beverly Hills Cancer Center - Beverly Hills
- Cancer and Blood Specialty Clinic - Lakewood
- Hoag Memorial Hospital - Newport Beach
Connecticut
- Hartford Hospital - Hartford
Florida
- Advent Health Orlando Hospital - Orlando
Nebraska
- Nebraska Cancer Specialists - Omaha
New Jersey
- Astera Cancer Care - East Brunswick
New York
- New York Cancer And Blood Specialists - Shirley
Oregon
- Oregon Health and Science University - Portland
South Carolina
- MUSC Hollings Cancer Center - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05865535
The ClinicalTrials.gov registry entry for NCT05865535 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 13 other Cachexia trials with a reported enrollment target (85% lower). The listed sponsor is AVEO Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cachexia appearing as the primary indexed condition, and to 1 intervention - of which AV-380 is the first listed.
NCT05865535 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT05865535 about?
NCT05865535 is a clinical study titled "A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia". This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiatio...
What is the current status of trial NCT05865535?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-06-13. Estimated completion is 2026-12-31.
What conditions does trial NCT05865535 study?
This clinical trial studies the following conditions: Cachexia.
What interventions are being tested in trial NCT05865535?
The interventions under investigation include: AV-380 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05865535?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05865535 being conducted?
This trial has 12 study locations across California, Connecticut, Florida, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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