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Maplirpacept

Phase 1

Non-Hodgkin Lymphoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 20, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05896774A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in ChinaPHASE1 COMPLETED 10 — — Jun 28, 2023Nov 6, 2024Nov 20, 20245 China
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Study Endpoints
Primary Endpoints
Number of Participants With Dose-Limiting Toxicity (DLT)
Cycle 1：up to 21 days

Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.

Single-dose Cmax
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Maximum Observed Plasma Concentration

Single-dose AUClast
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Single-dose AUCtau
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.

Secondary Endpoints
Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment
Baseline up to 28 days after the last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Baseline up to 28 days after the last dose of study drug
Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
0, 1, 2, 4, 24, 72 hours post-dose up to Day8
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Maplirpacept (PF-07901801)EXPERIMENTALsingle arm study
Interventions
NameTypeDescription
MaplirpaceptDRUGStudy drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: * Histologically confirmed relapsed/refractory non-Hodgkin lymphoma without other effective therapeutic option. Or relapsed/refractory multiple myeloma exposed to therapies including PI, IMiD and anti-CD38 antibody. * With measurable disease * Eastern Cooperative Oncology Gr...

Countries:China
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