A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China

Pfizer10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Histologically confirmed relapsed/refractory non-Hodgkin lymphoma without other effective therapeutic option. Or relapsed/refractory multiple myeloma exposed to therapies including PI, IMiD and anti-CD38 antibody. * With measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Adequate organ functions (including hematologic status, coagulation, hepatic, and renal) Key Exclusion Criteria: * Active plasma cell leukemia, or POEMS syndrome. * Known, current central nervous system disease involvement. * Significant cardiovascular disease. * Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent. * Radiation therapy within 14 days of study treatment administration. * Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or participants with active GVHD disease. * Use of any anticancer drug within 14 days before planned start of study treatment. * Prior anti-CD47 or anti-SIRP alpha therapy. * Participation in other studies involving investigational drug(s) or vaccines within 4 weeks from the last dose * Known active, uncontrolled bacterial, fungal, or viral infection.

Locations (5)

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

Outcomes

Primary Outcomes

Number of Participants With Dose-Limiting Toxicity (DLT)

Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.

Time frame: Cycle 1：up to 21 days

Single-dose Cmax

Maximum Observed Plasma Concentration

Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Single-dose AUClast

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Single-dose AUCtau

Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.

Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Secondary Outcomes

Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. Relatedness to study drug was assessed by the investigator.

Time frame: Baseline up to 28 days after the last dose of study drug

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion.

Time frame: Baseline up to 28 days after the last dose of study drug

Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)