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AN OPEN-LABEL, PHASE 1 STUDY EVALUATING THE PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF PF-07901801 (TTI-622) MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED HEMATOLOGIC MALIGNANCIES
The purpose of this study is to learn about the safety and what the body does to the medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple myeloma. Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). This study is seeking participants who: * have non-Hodgkin lymphoma or multiple myeloma. * have worsened with (or lack of improvement to) a standard treatment taken before. * have relatively normal functioning organs. All participants in this study will receive Maplirpacept as an intravenous (IV) infusion (given directly into a vein) at the study clinic every week. Participants will continue to receive Maplirpacept until: * the cancer worsens. * some serious side effects show up. * the participants do not wish to take the study medicine any more. The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine Maplirpacept, is safe and can be given to Chinese people.
The study is composed of 2 parts. In Part A, approximately 3-6 participants are expected to be enrolled to confirm the tolerability in Chinese participants. If deemed safe, the enrollment of Part B will proceed to include a total of approximately 9 participants in the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy of single agent PF-07901801 (Maplirpacept).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Start Date
June 28, 2023
Primary Completion Date
November 6, 2024
Completion Date
November 6, 2024
Last Updated
November 20, 2024
10
ACTUAL participants
Maplirpacept
DRUG
Lead Sponsor
Pfizer
NCT06152575
NCT06179888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04973605