Lymphoma, Multiple Myeloma
Conditions
Keywords
Lymphoma, multiple myeloma, maplirpacept, TTI-622, PF-07901801, C4971009, Phase 1, Japan
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.
Interventions
maplirpacept (PF-07901801)
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma | up to 21 days | Number of participants with DLTs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma | Through study completion, up to 18 monghs | overll safety profile of maplirpacept (PF-07901801) |
| Number of adverse events as characterized by type | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of adverse events as characterized by frequency | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of adverse events as characterized by severity | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of adverse events as characterized by timing | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of adverse events as characterized by relationship to maplirpacept (PF-07901801) | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of adverse events as characterized by seriousness | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| time to maximum concentration,ss of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| area under the curve last,ss of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| area under the curve tau,ss of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| time to maximum concentration of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing | Through study completion, up to 18 months | overall safety profile of maplirpacept (PF-07901801) |
| area under the curve last of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| clearance of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| area under the curve tau of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| volume of distribution at steady-state of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| area under the curve inf of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| terminal elimination half-life off maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| maximum observed concentration of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
| Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801) | Through study completion, up to 18 months | immunogenicity of maplirpacept (PF-07901801) |
| Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801) | Through study completion, up to 18 months | immunogenicity of maplirpacept (PF-07901801) |
| overall response rate | 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) |
| progression free survival | 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) |
| time to response | 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) |
| duration of response | 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) |
| trough concentration of maplirpacept (PF-07901801) | Through study completion, up to 18 months | pharmacokinetics of maplirpacept (PF-07901801) |
Countries
Japan
Outcome results
None listed