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

NCT05865535 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AV-380-22-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 12

Brief 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

Cachexia

Outcome Measures

Primary Outcomes (3)

• Assessment of adverse events (AEs)

  AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\])

  From enrollment to the last follow-up visit approximately 60-days post dose

• Toxicity

  Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380

  While receiving study drug (up to 4 months)

• Laboratory Abnormalities

  Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.

  From enrollment to the last follow-up visit approximately 60-days post dose.

Secondary Outcomes (3)

• Cmax

  From first dose to the last follow-up visit approximately 60-days post dose.

• Tmax

  From first dose to the last follow-up visit approximately 60-days post dose

• AUC(0-t)

  From first dose to the last follow-up visit approximately 60-days post dose.

Other Outcomes (9)

• Immunogenicity

  From first dose to the last follow-up visit approximately 60-days post dose.

• Weight

  From enrollment to the last follow-up visit approximately 60-days post dose.

• Patient-Reported Outcomes

  From enrollment to the end of treatment, approximately 4 months

Study Arms (1)

Dose Escalation Cohorts

EXPERIMENTAL

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

Biological: AV-380

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.

Dose Escalation Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be ≥ 18 years of age at the time of signing the informed consent.
• Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
• Patients with cachexia as defined by Fearon criteria:
• Weight loss \> 5% over past 6 months (in absence of simple starvation), or
• BMI \< 20 kg/m2 and any degree of weight loss \> 2%, or
• Sarcopenia and any degree of weight loss \> 2%
• Patients with life expectancy ≥ 3 months

You may not qualify if:

• History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.
• Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
• Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
• Patients receiving tube feedings or parenteral nutrition at the time of Screening.

Sponsors & Collaborators

• AVEO Pharmaceuticals, Inc.: lead

Study Sites (12)

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

RECRUITING

Cancer and Blood Specialty Clinic

Lakewood, California, 90712, United States

RECRUITING

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Advent Health Orlando Hospital

Orlando, Florida, 32804, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

New York Cancer And Blood Specialists

Shirley, New York, 11967, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

RECRUITING

Community Clinical Trials

Kingwood, Texas, 77339, United States

RECRUITING

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Central Study Contacts

AVEO Clinical Trials Office

CONTACT

(857)400-0101; clinical@aveooncology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 19, 2023
• Study Start: June 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)