A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies

November 5, 2024 updated by: Pfizer

A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TTI-622 (PF-07901801), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED OR REFRACTORY LYMPHOMA

The purpose of this clinical trial is to learn about how safe and tolerable is the study medicine (called maplirpacept (PF-07901801)) when taken for the treatment of lymphoma or multiple myeloma (a type of cancer that affects your body's infection-fighting cells, lymphocytes or plasma cell).

This study is seeking participants who:

  • are 18 years of age or older
  • have worsening and difficult to manage type of lymphoma or multiple myeloma
  • Have adequately functioning organs
  • are not on long term use of steroids which are given either by mouth or as shots
  • have no major heart related disease etc.

All participants in this study will receive maplirpacept (PF-07901801) as an IV infusion (given directly into a vein) at the study clinic every week.

Participants will continue to receive maplirpacept (PF-07901801) until their progress of cancer worsens or the participants do not wish to take the study medicine.

The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine maplirpacept (PF-07901801), is safe and can be given to Japanese people.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells. Maplirpacept (PF-07901801) is a soluble recombinant fusion protein created by directly linking the sequences encoding the CD47 binding domain of human Signal Regulatory Protein alpha with the fragment crystallizable domain of human Immunoglobulin 4. maplirpacept (PF-07901801) functions as a soluble decoy receptor, preventing CD47 from delivering its antiphagocytic signal. Neutralization of the inhibitory CD47 signal enables macrophage activation and anti-tumor effects by pro-phagocytic signals present on the tumor cells.

The objective of this study is to confirm safety and tolerability of single agent maplirpacept (PF-07901801) at the recommended phase 3 dose in Japanese participants with relapsed or refractory lymphoma or multiple myeloma.

Study Type

Interventional

Enrollment (Actual)

7

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 Locations

  • Japan
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8650
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research
      • Koto, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's) or multiple myeloma
  • Disease must have progressed with standard anticancer therapies
  • measurable disease
  • Capable of giving signed informed consent
  • Eastern cooperative oncology group performance status 0 or 1
  • Adequate organ functions

Exclusion Criteria:

  • Known, current central nervous system or interstitial lung disease involvement
  • History of hemolytic anemia or positive direct antiglobulin test or active bleeding disorder
  • Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent
  • Significant cardiovascular disease
  • Other significant medical condition unrelated to the primary malignancy
  • Radiation therapy within 14 days of study treatment administration
  • Hematopoietic stem cell transplant within 90 days before the planned start of study treatment
  • Antiplatelet/anticoagulant agents within 14 days before planned start of study treatment
  • Patients sustaining major surgery at least 4 weeks prior to study enrollment
  • Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment
  • Prior anti-CD47 and anti-Signal Regulatory Protein alpha therapy
  • Active, uncontrolled bacterial, fungal, or viral infection
  • Investigator site staff directly involved in the conduct of the study and their family members

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: maplirpacept (PF-07901801)
Drug: maplirpacept (PF-07901801)
maplirpacept (PF-07901801)
Other Names:
  • TTI-622

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
Time Frame: up to 21 days
Number of participants with DLTs
up to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events as characterized by type
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of adverse events as characterized by frequency
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of adverse events as characterized by severity
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of adverse events as characterized by timing
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of adverse events as characterized by seriousness
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing
Time Frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma
Time Frame: Through study completion, up to 18 monghs
overll safety profile of maplirpacept (PF-07901801)
Through study completion, up to 18 monghs
maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
time to maximum concentration,ss of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
area under the curve last,ss of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
area under the curve tau,ss of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
time to maximum concentration of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
trough concentration of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
area under the curve last of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
clearance of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
area under the curve tau of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
volume of distribution at steady-state of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
area under the curve inf of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
terminal elimination half-life off maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
maximum observed concentration of maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
immunogenicity of maplirpacept (PF-07901801)
Through study completion, up to 18 months
Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)
Time Frame: Through study completion, up to 18 months
immunogenicity of maplirpacept (PF-07901801)
Through study completion, up to 18 months
overall response rate
Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
preliminary antitumor activity of maplirpacept (PF-07901801)
From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
progression free survival
Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
preliminary antitumor activity of maplirpacept (PF-07901801)
From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
time to response
Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
preliminary antitumor activity of maplirpacept (PF-07901801)
From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
duration of response
Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
preliminary antitumor activity of maplirpacept (PF-07901801)
From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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)

November 2, 2022

Primary Completion (Actual)

October 2, 2024

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4971009

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.

Clinical Trials on Lymphoma

Clinical Trials on maplirpacept (PF-07901801)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe