Spots Global Cancer Trial Database for A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
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Trial Identification
Brief Title: A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
Official Title: A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
Study ID: NCT05544929
Conditions
Study Description
Brief Summary: The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.
Detailed Description: This is a phase I, open-label, multi-center study of KFA115 as a single agent and in combination with pembrolizumab. The study consists of a dose escalation part, followed by dose expansion part(s) for single-agent KFA115 and KFA115 in combination with pembrolizumab. The escalation parts will characterize safety and tolerability. After the determination of the maximum tolerated dose (MTD) / recommended dose (RD), the dose expansion parts will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at MTD/RD.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Massachusetts General Hospital ., Boston, Massachusetts, United States
NYU School of Medicine Langone Health, New York, New York, United States
University of Pittsburgh MC, Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners Sarah Cannon new location, Nashville, Tennessee, United States
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Shatin New Territories, , Hong Kong
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Chuo ku, Tokyo, Japan
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Taipei, , Taiwan
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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