A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia (NCT05865535) | Clinical Trial Compass
RecruitingPhase 1
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
United States30 participantsStarted 2023-06-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Assessment of adverse events (AEs)
Timeframe: From enrollment to the last follow-up visit approximately 60-days post dose
2
Toxicity
Timeframe: While receiving study drug (up to 4 months)
3
Laboratory Abnormalities
Timeframe: From enrollment to the last follow-up visit approximately 60-days post dose.