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

Phase 1

Recruiting

• Conditions: Cachexia
• Interventions: Biological: AV-380

• Registration Number: NCT05865535
• Lead Sponsor: AVEO Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-19
• Study Start: 2023-06-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patient must be ≥ 18 years of age at the time of signing the informed consent.

2. Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.

3. Patients with cachexia as defined by Fearon criteria:

   1. Weight loss > 5% over past 6 months (in absence of simple starvation), or
   2. BMI < 20 kg/m2 and any degree of weight loss > 2%, or
   3. Sarcopenia and any degree of weight loss > 2%

4. Patients with life expectancy ≥ 3 months

Exclusion Criteria

1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
2. 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.
3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
5. 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.
6. Patients receiving tube feedings or parenteral nutrition at the time of Screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation Cohorts	AV-380	Experimental: Dose escalation cohorts of AV-380 administered by IV infusion

Primary Outcome Measures

Name	Time	Method
Assessment of adverse events (AEs)	From enrollment to the last follow-up visit approximately 60-days post dose	AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\])
Toxicity	While receiving study drug (up to 4 months)	Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380
Laboratory Abnormalities	From enrollment to the last follow-up visit approximately 60-days post dose.	Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.

Secondary Outcome Measures

Name	Time	Method
Cmax	From first dose to the last follow-up visit approximately 60-days post dose.	Maximum observed plasma concentration for AV-380
Tmax	From first dose to the last follow-up visit approximately 60-days post dose	Time to reach the Cmax for AV-380
AUC(0-t)	From first dose to the last follow-up visit approximately 60-days post dose.	Area under the plasma concentration-time curve from zero time to the last measurable point for AV-380

Trial Locations

Locations (10)

Beverly Hills Cancer Center; 🇺🇸 Beverly Hills, California, United States

Nebraska Cancer Specialists; 🇺🇸 Omaha, Nebraska, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Cancer and Blood Specialty Clinic; 🇺🇸 Lakewood, California, United States

Advent Health Orlando Hospital; 🇺🇸 Orlando, Florida, United States

Piedmont Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

New York Cancer And Blood Specialists; 🇺🇸 Shirley, New York, United States

MUSC Hollings Cancer Center; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University Henry-Joyce Cancer Clinic; 🇺🇸 Nashville, Tennessee, United States

Community Clinical Trials; 🇺🇸 Kingwood, Texas, United States