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Recruiting NCT05865535

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

Phase I Interventional Cachexia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AV-380.
Who it may be relevant to
Registry conditions: Cachexia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Biological AV-380
    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.

Primary outcome measures

  • Assessment of adverse events (AEs) [Time frame: From enrollment to the last follow-up visit approximately 60-days post dose]
  • Toxicity [Time frame: While receiving study drug (up to 4 months)]
  • Laboratory Abnormalities [Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.]
Secondary outcome measures (3)
  • Cmax [Time frame: From first dose to the last follow-up visit approximately 60-days post dose.]
  • Tmax [Time frame: From first dose to the last follow-up visit approximately 60-days post dose]
  • AUC(0-t) [Time frame: From first dose to the last follow-up visit approximately 60-days post dose.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Beverly Hills Cancer Center — Beverly Hills
  • Cancer and Blood Specialty Clinic — Lakewood
  • Hoag Memorial Hospital — Newport Beach
  • Hartford Hospital — Hartford
  • Advent Health Orlando Hospital — Orlando
  • Nebraska Cancer Specialists — Omaha
  • Astera Cancer Care — East Brunswick
  • New York Cancer And Blood Specialists — Shirley
  • … and 4 more centers

Identifiers

NCT: NCT05865535 · AV-380-22-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗