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New treatment option for Cachexia
Official title A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
ClinicalTrials.gov ID: NCT05865535
What this study is testing
What is AV-380?
AV-380 is an investigational medicine, being studied as a potential treatment for cachexia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 \ 2%, or
You likely can't join if
- 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...
- 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...
- Patients receiving tube feedings or parenteral nutrition at the time of Screening.
See the full eligibility 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 \ 2%, or
- Sarcopenia and any degree of weight loss \> 2%
- Patients with life expectancy ≥ 3 months
- 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...
- Patients receiving tube feedings or parenteral nutrition at the time of Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Lakewood, California, United States
- Newport Beach, California, United States
- Hartford, Connecticut, United States
- Orlando, Florida, United States
- Omaha, Nebraska, United States
- East Brunswick, New Jersey, United States
- Shirley, New York, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Kingwood, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Lakewood, California, United States; Newport Beach, California, United States; Hartford, Connecticut, United States; Orlando, Florida, United States; Omaha, Nebraska, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.