A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
ConditionCachexia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAVEO Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- AV-380
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov