NCT05865535 A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
| NCT ID | NCT05865535 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AVEO Pharmaceuticals, Inc. |
| Condition | Cachexia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-13 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-06-13 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05865535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cachexia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05865535 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05865535 currently recruiting?
Yes, NCT05865535 is actively recruiting participants. Contact the research team at clinical@aveooncology.com for enrollment information.
Where is the NCT05865535 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Lakewood, United States, Newport Beach, United States, Hartford, United States and 8 additional locations.
Who is sponsoring the NCT05865535 clinical trial?
NCT05865535 is sponsored by AVEO Pharmaceuticals, Inc.. The trial plans to enroll 30 participants.