Spots Global Cancer Trial Database for GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
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Trial Identification
Brief Title: GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
Official Title: A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer
Study ID: NCT06046274
Conditions
Study Description
Brief Summary: The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are: * How well acasunlimab in combination with pembrolizumab works against endometrial cancer * What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.
Detailed Description: This is an open-label multicenter study in participants with advanced (unresectable and/or metastatic) endometrial cancer to evaluate the safety and clinical activity of acasunlimab (GEN1046) in combination with immunotherapy. The trial consists of two cohorts: * Cohort A (cohort closed) * Cohort B The study will enroll approximately 80 participants in Cohort A and B (approximately 40 participants in each cohort).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Orlando Health Cancer Institute, Orlando, Florida, United States
Rudgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Cliniques Universitaires Saint-Luc, Brussel, , Belgium
Grand Hospital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Ghent, Ghent, , Belgium
UZ Leuven, Leuven, , Belgium
Aalborg University Hospital, Aalborg, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Odense Universitetshospital, Odense, , Denmark
AOU Policlinico Sant'Orsola Malpighi IRCCS, Bologna, , Italy
IRCCS Istituto Europeo di Oncologia IEO, Milano, , Italy
Fondazione G. Pascale, Napoli, , Italy
IRCCS Policlinico Universitario Agostino Gemelli, Roma, , Italy
Ospedale Mauriziano Umberto I, Torino, , Italy
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
National Cancer Center Korea, Goyang-si, , Korea, Republic of
Pusan National University, Pusan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System|Division of Infectious Diseases, Seoul, , Korea, Republic of
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
ICO Girona, Girona, , Spain
Clínica Universidad de Navarra, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Fundacion Jiménez Díaz, Madrid, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Contact Details
Name: Study Official
Affiliation: Genmab
Role: STUDY_DIRECTOR
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