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

NCT05567887 | Completed Phase 1

• 1 other identifier: C4971009
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Lymphoma; Multiple Myeloma

Keywords

Lymphoma; multiple myeloma; maplirpacept; TTI-622; PF-07901801; C4971009; Phase 1; Japan

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma

  Number of participants with DLTs

  up to 21 days

Secondary Outcomes (31)

• Number of adverse events as characterized by type

  Through study completion, up to 18 months

• Number of adverse events as characterized by frequency

  Through study completion, up to 18 months

• Number of adverse events as characterized by severity

  Through study completion, up to 18 months

• Number of adverse events as characterized by timing

  Through study completion, up to 18 months

• Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)

  Through study completion, up to 18 months

Study Arms (1)

maplirpacept (PF-07901801)

EXPERIMENTAL

maplirpacept (PF-07901801)

Drug: maplirpacept (PF-07901801)

Interventions

maplirpacept (PF-07901801) DRUG

maplirpacept (PF-07901801)

Also known as: TTI-622

maplirpacept (PF-07901801)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Japanese Foundation for Cancer Research

Koto, Tokyo, 135-8550, Japan

Location

The Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 5, 2022
• Study Start: November 2, 2022
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)