A Phase I Study of SGN-BB228 in Patients with Advanced Melanoma and Other Solid Tumors
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
• 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)
Critères d'exclusion
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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Seagen Inc., (A wholly owned subsidiary of Pfizer Inc.), 21823 30th Drive SE, Bothell, WA 98021, United States
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr.med.Dr.sc.med Egle Ramelyte
+41 44 255 11 11
Egle.Ramelyte@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
30.05.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
A phase 1 study of PF-08046049/SGN-BB228 in advanced melanoma and other solid tumors (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible