Back to resultsA Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies
Primary Purpose
Lymphoma, Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
maplirpacept (PF-07901801)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, multiple myeloma, maplirpacept, TTI-622, PF-07901801, C4971009, Phase 1, Japan
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's)
- 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
Sites / Locations
- Japanese Red Cross Aichi Medical Center Nagoya Daini HospitalRecruiting
- Japanese Foundation for Cancer ResearchRecruiting
- Yamagata University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
maplirpacept (PF-07901801)
Arm Description
maplirpacept (PF-07901801)
Outcomes
Primary Outcome Measures
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
Number of participants with DLTs
Secondary Outcome Measures
Number of adverse events as characterized by type
overall safety profile of maplirpacept (PF-07901801)
Number of adverse events as characterized by frequency
overall safety profile of maplirpacept (PF-07901801)
Number of adverse events as characterized by severity
overall safety profile of maplirpacept (PF-07901801)
Number of adverse events as characterized by timing
overall safety profile of maplirpacept (PF-07901801)
Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)
overall safety profile of maplirpacept (PF-07901801)
Number of adverse events as characterized by seriousness
overall safety profile of maplirpacept (PF-07901801)
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type
overall safety profile of maplirpacept (PF-07901801)
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency
overall safety profile of maplirpacept (PF-07901801)
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity
overall safety profile of maplirpacept (PF-07901801)
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing
overall safety profile of maplirpacept (PF-07901801)
Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma
overll safety profile of maplirpacept (PF-07901801)
maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
time to maximum concentration,ss of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
area under the curve last,ss of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
area under the curve tau,ss of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
time to maximum concentration of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
trough concentration of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
area under the curve last of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
clearance of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
area under the curve tau of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
volume of distribution at steady-state of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
area under the curve inf of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
terminal elimination half-life off maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
maximum observed concentration of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)
immunogenicity of maplirpacept (PF-07901801)
Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)
immunogenicity of maplirpacept (PF-07901801)
overall response rate
preliminary antitumor activity of maplirpacept (PF-07901801)
progression free survival
preliminary antitumor activity of maplirpacept (PF-07901801)
time to response
preliminary antitumor activity of maplirpacept (PF-07901801)
duration of response
preliminary antitumor activity of maplirpacept (PF-07901801)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05567887
Brief Title
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 HEMATOLOGIC MALIGNANCIES
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma
Keywords
Lymphoma, multiple myeloma, maplirpacept, TTI-622, PF-07901801, C4971009, Phase 1, Japan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
maplirpacept (PF-07901801)
Arm Type
Experimental
Arm Description
maplirpacept (PF-07901801)
Intervention Type
Drug
Intervention Name(s)
maplirpacept (PF-07901801)
Other Intervention Name(s)
TTI-622
Intervention Description
maplirpacept (PF-07901801)
Primary Outcome Measure Information:
Title
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
Description
Number of participants with DLTs
Time Frame
up to 21 days
Secondary Outcome Measure Information:
Title
Number of adverse events as characterized by type
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of adverse events as characterized by frequency
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of adverse events as characterized by severity
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of adverse events as characterized by timing
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of adverse events as characterized by seriousness
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing
Description
overall safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma
Description
overll safety profile of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 monghs
Title
maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
time to maximum concentration,ss of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
area under the curve last,ss of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
area under the curve tau,ss of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
time to maximum concentration of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
trough concentration of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
area under the curve last of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
clearance of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
area under the curve tau of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
volume of distribution at steady-state of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
area under the curve inf of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
terminal elimination half-life off maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
maximum observed concentration of maplirpacept (PF-07901801)
Description
pharmacokinetics of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)
Description
immunogenicity of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)
Description
immunogenicity of maplirpacept (PF-07901801)
Time Frame
Through study completion, up to 18 months
Title
overall response rate
Description
preliminary antitumor activity of maplirpacept (PF-07901801)
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
Title
progression free survival
Description
preliminary antitumor activity of maplirpacept (PF-07901801)
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
Title
time to response
Description
preliminary antitumor activity of maplirpacept (PF-07901801)
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
Title
duration of response
Description
preliminary antitumor activity of maplirpacept (PF-07901801)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4971009
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies
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