Badanie eskalacji dawki AV-380 u pacjentów z rakiem z przerzutami i wyniszczeniem
Badanie fazy 1 zwiększania dawki AV-380 w skojarzeniu ze standardową chemioterapią u pacjentów z rakiem przerzutowym z wyniszczeniem i podwyższonym poziomem GDF-15
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.
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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California
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Beverly Hills, California, Stany Zjednoczone, 90211
- Beverly Hills Cancer Center
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Lakewood, California, Stany Zjednoczone, 90712
- Cancer and Blood Specialty Clinic
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Newport Beach, California, Stany Zjednoczone, 92663
- Hoag Memorial Hospital
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Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06102
- Hartford Hospital
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Florida
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Orlando, Florida, Stany Zjednoczone, 32804
- Advent Health Orlando Hospital
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68130
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, Stany Zjednoczone, 08816
- Astera Cancer Care
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New York
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Shirley, New York, Stany Zjednoczone, 11967
- New York Cancer And Blood Specialists
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97239
- Oregon Health and Science University
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425
- MUSC Hollings Cancer Center
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University Henry-Joyce Cancer Clinic
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Texas
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Kingwood, Texas, Stany Zjednoczone, 77339
- Community Clinical Trials
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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Patient must be ≥ 18 years of age at the time of signing the informed consent.
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Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
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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%
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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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Dose Escalation Cohorts
Experimental: Dose escalation cohorts of AV-380 administered by IV infusion |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Assessment of adverse events (AEs)
Ramy czasowe: From enrollment to the last follow-up visit approximately 60-days post dose
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AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]) |
From enrollment to the last follow-up visit approximately 60-days post dose
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Toxicity
Ramy czasowe: While receiving study drug (up to 4 months)
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Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380 |
While receiving study drug (up to 4 months)
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Laboratory Abnormalities
Ramy czasowe: From enrollment to the last follow-up visit approximately 60-days post dose.
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Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing. |
From enrollment to the last follow-up visit approximately 60-days post dose.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cmax
Ramy czasowe: From first dose to the last follow-up visit approximately 60-days post dose.
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Maximum observed plasma concentration for AV-380 |
From first dose to the last follow-up visit approximately 60-days post dose.
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Tmax
Ramy czasowe: From first dose to the last follow-up visit approximately 60-days post dose
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Time to reach the Cmax for AV-380 |
From first dose to the last follow-up visit approximately 60-days post dose
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AUC(0-t)
Ramy czasowe: From first dose to the last follow-up visit approximately 60-days post dose.
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Area under the plasma concentration-time curve from zero time to the last measurable point for AV-380 |
From first dose to the last follow-up visit approximately 60-days post dose.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Poziom GDF-15 w surowicy
Ramy czasowe: Od rejestracji do ostatniej wizyty kontrolnej około 60 dni po dawce.
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Od rejestracji do ostatniej wizyty kontrolnej około 60 dni po dawce.
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Immunogenicity
Ramy czasowe: From first dose to the last follow-up visit approximately 60-days post dose.
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Serum levels of Anti-Drug Antibody (ADA) against AV-380 and their potential relationship with AEs and serum levels of GDF-15 |
From first dose to the last follow-up visit approximately 60-days post dose.
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Weight
Ramy czasowe: From enrollment to the last follow-up visit approximately 60-days post dose.
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Change from baseline body weight during the study |
From enrollment to the last follow-up visit approximately 60-days post dose.
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Patient-Reported Outcomes
Ramy czasowe: From enrollment to the end of treatment, approximately 4 months
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Change from baseline in the following questionnaires: Functional Assessment of Anorexia Cachexia Therapy (FAACT); Patient global impression of severity (PGI-S) and patient global impression of change (PGI-C) for appetite, fatigue, and physical activity. |
From enrollment to the end of treatment, approximately 4 months
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Lumbar (L3) Skeletal Muscle Index (L3SMI)
Ramy czasowe: From enrollment to the end of treatment, approximately 4 months
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Measurement of a cross-sectional area of muscle at the level of the third lumbar vertebra (L3) using computed tomography (CT) scan |
From enrollment to the end of treatment, approximately 4 months
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Physical Function
Ramy czasowe: From enrollment to the end of treatment, approximately 4 months
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Change from baseline in physical function endpoints, including Short Physical Performance Battery test and digital measures of non-sedentary time |
From enrollment to the end of treatment, approximately 4 months
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Albumin and CRP
Ramy czasowe: From enrollment to the last follow-up visit approximately 60-days post dose.
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Change from baseline in albumin and CRP levels |
From enrollment to the last follow-up visit approximately 60-days post dose.
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Tumor status
Ramy czasowe: From enrollment to the last follow-up visit approximately 60-days post dose.
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Evaluate the effect of AV-380 on tumor burden and tumor status, per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) |
From enrollment to the last follow-up visit approximately 60-days post dose.
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Biomarkers
Ramy czasowe: From first dose to the last follow-up visit approximately 60-days post dose.
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including activin A and cytokine levels (e.g., monocyte chemoattractant protein-1 [MCP-1] and proinflammatory) |
From first dose to the last follow-up visit approximately 60-days post dose.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AV-380-22-102
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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