A Phase I Study of SGN-BB228 in Patients with Advanced Melanoma and Other Solid Tumors
Descrizione riassuntiva dello studio
We are studying SGN-BB228 to find out what side effects it has and whether it works for certain types of cancer. We also want to find out if SGN-BB228 is effective in treating certain cancers and learn more about the best dose. This study is conducted in three parts. In Part A of the study, we examine SGN-BB228 to find the best dose. In Part B of the study, we may use the information obtained in Part A to continue studying the best dose and schedule for SGN-BB228. In Part C of the study, we use what we have learned about the best dose and schedule to investigate how SGN-BB228 works in the treatment of skin cancer and some other cancers.
(BASEC)
Intervento studiato
The investigational drug will be administered over a period referred to as a "cycle".
• Part A: SGN-BB228 is administered intravenously (i.v.) on Days 1 and 15 of each 4-week cycle.
• Part B: We may administer SGN-BB228 i.v. according to one of the following schedules:
o On Days 1, 8, and 15 of each 3-week cycle.
o On Day 1 of each 3-week cycle.
We may also investigate other dosing regimens in Parts A and B of the study.
Part C: We may administer SGN-BB228 according to one of the above schedules every 3 or 4 weeks.
(BASEC)
Malattie studiate
• Melanoma • Lung cancer • Colorectal cancer • Pancreatic cancer • Mesothelioma
(BASEC)
1. Participants who are at least 18 years old. 2. Participants with a confirmed metastatic or inoperable cutaneous melanoma. 3. Participants with one of the following histologically or cytologically confirmed metastatic or inoperable solid malignancies within one of the tumor types listed below: • Melanoma • Lung cancer • Colorectal cancer • Pancreatic cancer • Mesothelioma (BASEC)
Criteri di esclusione
1. History of another malignancy within 3 years prior to the first dose of the study drug or evidence of residual disease from a previously diagnosed malignancy. 2. Known active metastases of the central nervous system 3. Any active viral, bacterial, or fungal infection within 2 weeks prior to the first dose of the study drug. (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Seagen Inc., (A wholly owned subsidiary of Pfizer Inc.), 21823 30th Drive SE, Bothell, WA 98021, United States
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr.med.Dr.sc.med Egle Ramelyte
+41 44 255 11 11
Egle.Ramelyte@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
30.05.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A phase 1 study of PF-08046049/SGN-BB228 in advanced melanoma and other solid tumors (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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