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

Multiple Myeloma Clinical Trial

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 LYMPHOMA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05567887
• Other study ID #: C4971009
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 2, 2022
• Est. completion date: July 10, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma

Intervention

Drug:
• maplirpacept (PF-07901801)
maplirpacept (PF-07901801)

Locations

Country	Name	City	State
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Koto	Tokyo
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital	Nagoya	Aichi
Japan	Yamagata University Hospital	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma	Number of participants with DLTs	up to 21 days
Secondary	Number of adverse events as characterized by type	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of adverse events as characterized by frequency	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of adverse events as characterized by severity	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of adverse events as characterized by timing	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of adverse events as characterized by seriousness	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing	overall safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma	overll safety profile of maplirpacept (PF-07901801)	Through study completion, up to 18 monghs
Secondary	maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	time to maximum concentration,ss of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	area under the curve last,ss of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	area under the curve tau,ss of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	time to maximum concentration of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	trough concentration of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	area under the curve last of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	clearance of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	area under the curve tau of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	volume of distribution at steady-state of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	area under the curve inf of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	terminal elimination half-life off maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	maximum observed concentration of maplirpacept (PF-07901801)	pharmacokinetics of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)	immunogenicity of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)	immunogenicity of maplirpacept (PF-07901801)	Through study completion, up to 18 months
Secondary	overall response rate	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
Secondary	progression free survival	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
Secondary	time to response	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
Secondary	duration of response	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

External Links

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