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

March 1, 2024 updated by: Pfizer

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Not yet recruiting
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maplirpacept (PF-07901801)
single arm study
Study drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles.
Other Names:
  • TTI-622
  • PF-07901801

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT)
Time Frame: Cycle 1:up to 21 days
Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.
Cycle 1:up to 21 days
Single-dose Cmax
Time Frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Maximum Observed Plasma Concentration
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Single-dose AUClast
Time Frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Single-dose AUCtau
Time Frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline up to 28 days after the last dose of study drug
Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion.
Baseline up to 28 days after the last dose of study drug
Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Time Frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day8
Pharmacokinetics of Maplirpacept
0, 1, 2, 4, 24, 72 hours post-dose up to Day8
Multiple-dose Cmax (Maximum Observed Plasma Concentration)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Multiple-dose Ctrough (trough concentration)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Multiple-dose Rac (Accumulation Ratio)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
CL (Systemic Clearance)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Vss (Volume of Distribution at Steady State)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
t½ (Plasma Decay Half-Life)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Incidence and titers of anti-drug antibodies against TTI-622
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Incidence and titers of neutralizing antibodies against TTI-622
Time Frame: Through study completion, up to 18 months
Pharmacokinetics of Maplirpacept
Through study completion, up to 18 months
Objective Response
Time Frame: Baseline to measured progressive disease, up to 18 months
To assess the preliminary antitumor activity of Maplirpacept
Baseline to measured progressive disease, up to 18 months
Time to Tumor Response (TTR)
Time Frame: Baseline to measured progressive disease, up to 18 months
To assess the preliminary antitumor activity of Maplirpacept
Baseline to measured progressive disease, up to 18 months
Duration of Response (DOR)
Time Frame: Baseline to measured progressive disease, up to 18 months
To assess the preliminary antitumor activity of Maplirpacept
Baseline to measured progressive disease, up to 18 months
Progression-Free Survival (PFS)
Time Frame: Baseline to measured progressive disease, up to 18 months
To assess the preliminary antitumor activity of Maplirpacept
Baseline to measured progressive disease, up to 18 months
Minimal Residual Disease (MRD)
Time Frame: Baseline to measured progressive disease, up to 18 months
To assess the preliminary antitumor activity of Maplirpacept. Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria.
Baseline to measured progressive disease, up to 18 months
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
Time Frame: Baseline up to 28 days after the last dose of study drug
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.
Baseline up to 28 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Estimated)

February 26, 2025

Study Completion (Estimated)

May 27, 2025

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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