Uno studio sull'aumento della dose di AV-380 in pazienti affetti da cancro metastatico con cachessia
Uno studio di fase 1 sull'aumento della dose di AV-380 in combinazione con la chemioterapia standard di cura in pazienti affetti da cancro metastatico con cachessia e livelli elevati di 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.
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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California
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Beverly Hills, California, Stati Uniti, 90211
- Beverly Hills Cancer Center
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Lakewood, California, Stati Uniti, 90712
- Cancer and Blood Specialty Clinic
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Newport Beach, California, Stati Uniti, 92663
- Hoag Memorial Hospital
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06102
- Hartford Hospital
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Florida
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Orlando, Florida, Stati Uniti, 32804
- Advent Health Orlando Hospital
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68130
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, Stati Uniti, 08816
- Astera Cancer Care
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New York
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Shirley, New York, Stati Uniti, 11967
- New York Cancer And Blood Specialists
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health and Science University
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- MUSC Hollings Cancer Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University Henry-Joyce Cancer Clinic
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Texas
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Kingwood, Texas, Stati Uniti, 77339
- Community Clinical Trials
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of adverse events (AEs)
Lasso di tempo: From enrollment to the last follow-up visit approximately 60-days post dose
|
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
|
|
Toxicity
Lasso di tempo: While receiving study drug (up to 4 months)
|
Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380 |
While receiving study drug (up to 4 months)
|
|
Laboratory Abnormalities
Lasso di tempo: From enrollment to the last follow-up visit approximately 60-days post dose.
|
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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cmax
Lasso di tempo: From first dose to the last follow-up visit approximately 60-days post dose.
|
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
Lasso di tempo: From first dose to the last follow-up visit approximately 60-days post dose
|
Time to reach the Cmax for AV-380 |
From first dose to the last follow-up visit approximately 60-days post dose
|
|
AUC(0-t)
Lasso di tempo: From first dose to the last follow-up visit approximately 60-days post dose.
|
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.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Livello sierico di GDF-15
Lasso di tempo: Dall'iscrizione all'ultima visita di follow-up circa 60 giorni dopo la dose.
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Dall'iscrizione all'ultima visita di follow-up circa 60 giorni dopo la dose.
|
|
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Immunogenicity
Lasso di tempo: From first dose to the last follow-up visit approximately 60-days post dose.
|
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
Lasso di tempo: From enrollment to the last follow-up visit approximately 60-days post dose.
|
Change from baseline body weight during the study |
From enrollment to the last follow-up visit approximately 60-days post dose.
|
|
Patient-Reported Outcomes
Lasso di tempo: From enrollment to the end of treatment, approximately 4 months
|
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
|
|
Lumbar (L3) Skeletal Muscle Index (L3SMI)
Lasso di tempo: From enrollment to the end of treatment, approximately 4 months
|
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
|
|
Physical Function
Lasso di tempo: From enrollment to the end of treatment, approximately 4 months
|
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
Lasso di tempo: 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
Lasso di tempo: From enrollment to the last follow-up visit approximately 60-days post dose.
|
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
Lasso di tempo: From first dose to the last follow-up visit approximately 60-days post dose.
|
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.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AV-380-22-102
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