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

• ClinicalTrials.gov Identifier: NCT05567887
• Recruitment Status: Recruiting
• First Posted: October 5, 2022
• Last Update Posted: May 8, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma; Multiple Myeloma	Drug: maplirpacept (PF-07901801)	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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 HEMATOLOGIC MALIGNANCIES
• Actual Study Start Date: November 2, 2022
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: maplirpacept (PF-07901801); maplirpacept (PF-07901801)	Drug: maplirpacept (PF-07901801); maplirpacept (PF-07901801); Other Name: TTI-622

Outcome Measures

Primary Outcome Measures :

1. Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma [ Time Frame: up to 21 days ]
   Number of participants with DLTs

Secondary Outcome Measures :

1. Number of adverse events as characterized by type [ Time Frame: Through study completion, up to 18 months ]
   overall safety profile of maplirpacept (PF-07901801)
2. Number of adverse events as characterized by frequency [ Time Frame: Through study completion, up to 18 months ]
   overall safety profile of maplirpacept (PF-07901801)
3. Number of adverse events as characterized by severity [ Time Frame: Through study completion, up to 18 months ]
   overall safety profile of maplirpacept (PF-07901801)
4. Number of adverse events as characterized by timing [ Time Frame: Through study completion, up to 18 months ]
   overall safety profile of maplirpacept (PF-07901801)
5. 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)
6. Number of adverse events as characterized by seriousness [ Time Frame: Through study completion, up to 18 months ]
   overall safety profile of maplirpacept (PF-07901801)
7. 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)
8. 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)
9. 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)
10. 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)
11. 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)
12. maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
13. time to maximum concentration,ss of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
14. area under the curve last,ss of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
15. area under the curve tau,ss of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
16. time to maximum concentration of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
17. trough concentration of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
18. area under the curve last of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
19. clearance of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
20. area under the curve tau of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
21. volume of distribution at steady-state of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
22. 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)
23. area under the curve inf of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
24. terminal elimination half-life off maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
25. maximum observed concentration of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    pharmacokinetics of maplirpacept (PF-07901801)
26. 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)
27. Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
    immunogenicity of maplirpacept (PF-07901801)
28. 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)
29. 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)
30. 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)
31. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Recruiting

Nagoya, Aichi, Japan, 466-8650

Japanese Foundation for Cancer Research; Recruiting

Koto, Tokyo, Japan, 135-8550

Yamagata University Hospital; Recruiting

Yamagata, Japan, 990-9585

Sponsors and Collaborators

Pfizer

Investigators

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

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05567887
• Other Study ID Numbers: C4971009
• First Posted: October 5, 2022
• Last Update Posted: May 8, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Multiple Myeloma; Hematologic Neoplasms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Neoplasms by Site