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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maplirpacept (PF-07901801) | Experimental | maplirpacept (PF-07901801) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maplirpacept (PF-07901801) | Drug | maplirpacept (PF-07901801) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma | Number of participants with DLTs | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events as characterized by type | overall safety profile of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| Number of adverse events as characterized by frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | Aichi-ken | 466-8650 | Japan | ||
| Japanese Foundation for Cancer Research |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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overall safety profile of maplirpacept (PF-07901801)
| Through study completion, up to 18 months |
| Number of adverse events as characterized by severity | overall safety profile of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| Number of adverse events as characterized by timing | overall safety profile of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| 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 |
| Number of adverse events as characterized by seriousness | overall safety profile of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| time to maximum concentration,ss of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| area under the curve last,ss of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| area under the curve tau,ss of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| time to maximum concentration of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| trough concentration of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| area under the curve last of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| clearance of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| area under the curve tau of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| volume of distribution at steady-state of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| 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 |
| area under the curve inf of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| terminal elimination half-life off maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| maximum observed concentration of maplirpacept (PF-07901801) | pharmacokinetics of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801) | immunogenicity of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801) | immunogenicity of maplirpacept (PF-07901801) | Through study completion, up to 18 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Koto |
| Tokyo |
| 135-8550 |
| Japan |
| The Cancer Institute Hospital of JFCR | Koto | Tokyo | 135-8550 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |