- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05896774
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China
AN OPEN-LABEL, PHASE 1 STUDY EVALUATING THE PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF PF-07901801 (TTI-622) MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED HEMATOLOGIC MALIGNANCIES
The purpose of this study is to learn about the safety and what the body does to the medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple myeloma.
Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies).
This study is seeking participants who:
- have non-Hodgkin lymphoma or multiple myeloma.
- have worsened with (or lack of improvement to) a standard treatment taken before.
- have relatively normal functioning organs.
All participants in this study will receive Maplirpacept as an intravenous (IV) infusion (given directly into a vein) at the study clinic every week.
Participants will continue to receive Maplirpacept until:
- the cancer worsens.
- some serious side effects show up.
- the participants do not wish to take the study medicine any more.
The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine Maplirpacept, is safe and can be given to Chinese people.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Beijing, Beijing, China, 100142
- Not yet recruiting
- Beijing Cancer Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Not yet recruiting
- Guangdong Provincial People's Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
- Not yet recruiting
- Sir Run Run Shaw Hospital
-
Hangzhou, Zhejiang, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Wenzhou, Zhejiang, China, 325000
- Not yet recruiting
- The First Affiliated Hospital of Wenzhou Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Group (ECOG) performance status score of 0, 1, or 2.
- Adequate organ functions (including hematologic status, coagulation, hepatic, and renal)
Key Exclusion Criteria:
- Active plasma cell leukemia, or POEMS syndrome.
- Known, current central nervous system disease involvement.
- Significant cardiovascular disease.
- Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.
- Radiation therapy within 14 days of study treatment administration.
- Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or participants with active GVHD disease.
- Use of any anticancer drug within 14 days before planned start of study treatment.
- Prior anti-CD47 or anti-SIRP alpha therapy.
- Participation in other studies involving investigational drug(s) or vaccines within 4 weeks from the last dose
- Known active, uncontrolled bacterial, fungal, or viral infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Maplirpacept (PF-07901801)
single arm study
|
Study drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Dose-Limiting Toxicity (DLT)
Time Frame: Cycle 1:up to 21 days
|
Part A only.
To characterize the dose limiting toxicities (DLTs) of Maplirpacept.
|
Cycle 1:up to 21 days
|
Single-dose Cmax
Time Frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
|
Maximum Observed Plasma Concentration
|
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
|
Single-dose AUClast
Time Frame: 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)
|
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
|
Single-dose AUCtau
Time Frame: 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.
|
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline up to 28 days after the last dose of study drug
|
Laboratory parameters included: hematology, blood chemistry and coagulation.
Clinical significance of laboratory parameters was determined at the investigator's discretion.
|
Baseline up to 28 days after the last dose of study drug
|
Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Time Frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day8
|
Pharmacokinetics of Maplirpacept
|
0, 1, 2, 4, 24, 72 hours post-dose up to Day8
|
Multiple-dose Cmax (Maximum Observed Plasma Concentration)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Multiple-dose Ctrough (trough concentration)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Multiple-dose Rac (Accumulation Ratio)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
CL (Systemic Clearance)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Vss (Volume of Distribution at Steady State)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
t½ (Plasma Decay Half-Life)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Incidence and titers of anti-drug antibodies against TTI-622
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Incidence and titers of neutralizing antibodies against TTI-622
Time Frame: Through study completion, up to 18 months
|
Pharmacokinetics of Maplirpacept
|
Through study completion, up to 18 months
|
Objective Response
Time Frame: Baseline to measured progressive disease, up to 18 months
|
To assess the preliminary antitumor activity of Maplirpacept
|
Baseline to measured progressive disease, up to 18 months
|
Time to Tumor Response (TTR)
Time Frame: Baseline to measured progressive disease, up to 18 months
|
To assess the preliminary antitumor activity of Maplirpacept
|
Baseline to measured progressive disease, up to 18 months
|
Duration of Response (DOR)
Time Frame: Baseline to measured progressive disease, up to 18 months
|
To assess the preliminary antitumor activity of Maplirpacept
|
Baseline to measured progressive disease, up to 18 months
|
Progression-Free Survival (PFS)
Time Frame: Baseline to measured progressive disease, up to 18 months
|
To assess the preliminary antitumor activity of Maplirpacept
|
Baseline to measured progressive disease, up to 18 months
|
Minimal Residual Disease (MRD)
Time Frame: Baseline to measured progressive disease, up to 18 months
|
To assess the preliminary antitumor activity of Maplirpacept.
Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria.
|
Baseline to measured progressive disease, up to 18 months
|
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
Time Frame: Baseline up to 28 days after the last dose of study drug
|
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose.
Participants with multiple occurrences of an AE within a category were counted once within the category.
Relatedness to study drug was assessed by the investigator.
|
Baseline up to 28 days after the last dose of study drug
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Lymphoma, Non-Hodgkin
Other Study ID Numbers
- C4971010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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