Clinical trial NCT05567887: A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Multiple Myeloma
Keywords: Lymphoma
multiple myeloma
maplirpacept
TTI-622
PF-07901801
C4971009
Phase 1
Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
timeFrame: up to 21 days
Secondary outcomes:
measure: Number of adverse events as characterized by type
timeFrame: Through study completion, up to 18 months
measure: Number of adverse events as characterized by frequency
timeFrame: Through study completion, up to 18 months
measure: Number of adverse events as characterized by severity
timeFrame: Through study completion, up to 18 months
measure: Number of adverse events as characterized by timing
timeFrame: Through study completion, up to 18 months
measure: Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: Number of adverse events as characterized by seriousness
timeFrame: Through study completion, up to 18 months
measure: Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type
timeFrame: Through study completion, up to 18 months
measure: Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency
timeFrame: Through study completion, up to 18 months
measure: Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity
timeFrame: Through study completion, up to 18 months
measure: Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing
timeFrame: Through study completion, up to 18 months
measure: Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma
timeFrame: Through study completion, up to 18 monghs
measure: maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: time to maximum concentration,ss of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: area under the curve last,ss of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: area under the curve tau,ss of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: time to maximum concentration of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: trough concentration of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: area under the curve last of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: clearance of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: area under the curve tau of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: volume of distribution at steady-state of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: area under the curve inf of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: terminal elimination half-life off maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: maximum observed concentration of maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)
timeFrame: Through study completion, up to 18 months
measure: overall response rate
timeFrame: 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
measure: progression free survival
timeFrame: 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
measure: time to response
timeFrame: 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
measure: duration of response
timeFrame: 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
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
state: Aichi
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Koto
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: