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Maplirpacept

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Maplirpacept · 2 trials · 3 indications

Phase 1 2
NCT05896774A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in ChinaNon-Hodgkin Lymphoma
COMPLETED10 Analytics
NCT05567887A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic MalignanciesLymphoma
COMPLETED7 Analytics
PHASE1COMPLETED
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China
Non-Hodgkin LymphomaUnlock trial analytics
PHASE1COMPLETED
A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies
LymphomaUnlock trial analytics

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.

Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
up to 21 days

Number of participants with DLTs

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.
maplirpacept (PF-07901801)DRUGmaplirpacept (PF-07901801)
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Eligibility Criteria

Age Range18 Years to 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:ChinaJapan
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Frequently asked questions about Maplirpacept

What is Maplirpacept used for?

Maplirpacept is an investigational small molecule being studied for the treatment of hematologic malignancies, specifically Non-Hodgkin Lymphoma and Lymphoma. It is also being evaluated in patients with Multiple Myeloma. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Maplirpacept?

Maplirpacept is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for the treatment of hematologic malignancies.

What phase is Maplirpacept in?

Maplirpacept is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage trials to evaluate its safety and tolerability in patients with Non-Hodgkin Lymphoma and other hematologic malignancies.

What clinical trials is Maplirpacept in?

Maplirpacept has been studied in two completed Phase 1 clinical trials. NCT05567887 evaluated the drug in Japanese patients with Lymphoma and Multiple Myeloma, enrolling 7 participants. NCT05896774 studied the drug in Chinese patients with Non-Hodgkin Lymphoma and Multiple Myeloma, enrolling 10 participants. Both trials were uncontrolled and not randomized.

Is Maplirpacept the same as PF-07901801?

Yes, Maplirpacept is also known as PF-07901801. Clinical trial NCT05567887 refers to the study medicine as Maplirpacept (PF-07901801), confirming that these names refer to the same investigational drug being developed by Pfizer.