A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia

Part of paid clinical trials in Beverly Hills, California.

Sponsor
AVEO Pharmaceuticals, Inc.
Study ID
NCT05865535
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cachexia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AV-380 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jun 13, 2023
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohorts
    Experimental: Dose escalation cohorts of AV-380 administered by IV infusion

Primary Outcome Measure

Assessment of adverse events (AEs) [ Time Frame: From enrollment to the last follow-up visit approximately 60-days post dose ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Cancer and Blood Specialty ClinicLakewoodCalifornia90712-
Hoag Memorial HospitalNewport BeachCalifornia92663-
Hartford HospitalHartfordConnecticut06102-
Advent Health Orlando HospitalOrlandoFlorida32804-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Astera Cancer CareEast BrunswickNew Jersey08816-
New York Cancer And Blood SpecialistsShirleyNew York11967-
Oregon Health and Science UniversityPortlandOregon97239-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
Vanderbilt University Henry-Joyce Cancer ClinicNashvilleTennessee37232-
Community Clinical TrialsKingwoodTexas77339-

Find similar trials in Beverly Hills, CA

By research site
Beverly Hills Cancer Center· Beverly Hills, CACancer and Blood Specialty Clinic· Lakewood, CAHoag Memorial Hospital· Newport Beach, CAHartford Hospital· Hartford, CTAdvent Health Orlando Hospital· Orlando, FLNebraska Cancer Specialists· Omaha, NE

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