RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels

Quick Facts

Study Start:2023-06-13

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05865535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

AVEO Clinical Trials Office

CONTACT

(857)400-0101

clinical@aveooncology.com

Study Locations (Sites)

Cancer and Blood Specialty Clinic

Lakewood, California, 90712

United States

Advent Health Orlando Hospital

Orlando, Florida, 32804

United States

Piedmont Cancer Institute

Atlanta, Georgia, 30318

United States

New York Cancer And Blood Specialists

Shirley, New York, 11967

United States

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425

United States

Vanderbilt University Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232

United States

Community Clinical Trials

Kingwood, Texas, 77339

United States

Collaborators and Investigators

Sponsor: AVEO Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-13

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-06-13

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Cachexia