Back to resultsA Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China
Primary Purpose
Non-Hodgkin Lymphoma, Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Maplirpacept
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Beijing Cancer Hospital
- Beijing Cancer HospitalRecruiting
- Guangdong Provincial People's Hospital
- Sir Run Run Shaw Hospital
- The First Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Maplirpacept (PF-07901801)
Arm Description
single arm study
Outcomes
Primary Outcome Measures
Number of Participants With Dose-Limiting Toxicity (DLT)
Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.
Single-dose Cmax
Maximum Observed Plasma Concentration
Single-dose AUClast
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Single-dose AUCtau
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.
Secondary Outcome Measures
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
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.
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
Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion.
Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Pharmacokinetics of Maplirpacept
Multiple-dose Cmax (Maximum Observed Plasma Concentration)
Pharmacokinetics of Maplirpacept
Multiple-dose Ctrough (trough concentration)
Pharmacokinetics of Maplirpacept
Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)
Pharmacokinetics of Maplirpacept
Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Pharmacokinetics of Maplirpacept
Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)
Pharmacokinetics of Maplirpacept
Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)
Pharmacokinetics of Maplirpacept
Multiple-dose Rac (Accumulation Ratio)
Pharmacokinetics of Maplirpacept
CL (Systemic Clearance)
Pharmacokinetics of Maplirpacept
Vss (Volume of Distribution at Steady State)
Pharmacokinetics of Maplirpacept
t½ (Plasma Decay Half-Life)
Pharmacokinetics of Maplirpacept
AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)
Pharmacokinetics of Maplirpacept
Incidence and titers of anti-drug antibodies against TTI-622
Pharmacokinetics of Maplirpacept
Incidence and titers of neutralizing antibodies against TTI-622
Pharmacokinetics of Maplirpacept
Objective Response
To assess the preliminary antitumor activity of Maplirpacept
Time to Tumor Response (TTR)
To assess the preliminary antitumor activity of Maplirpacept
Duration of Response (DOR)
To assess the preliminary antitumor activity of Maplirpacept
Progression-Free Survival (PFS)
To assess the preliminary antitumor activity of Maplirpacept
Minimal Residual Disease (MRD)
To assess the preliminary antitumor activity of Maplirpacept. Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05896774
Brief Title
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
August 24, 2024 (Anticipated)
Study Completion Date
November 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
The study is composed of 2 parts. In Part A, approximately 3-6 participants are expected to be enrolled to confirm the tolerability in Chinese participants. If deemed safe, the enrollment of Part B will proceed to include a total of approximately 9 participants in the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy of single agent PF-07901801 (Maplirpacept).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maplirpacept (PF-07901801)
Arm Type
Experimental
Arm Description
single arm study
Intervention Type
Drug
Intervention Name(s)
Maplirpacept
Other Intervention Name(s)
PF-07901801, TTI-622
Intervention Description
Study drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles.
Primary Outcome Measure Information:
Title
Number of Participants With Dose-Limiting Toxicity (DLT)
Description
Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.
Time Frame
Cycle 1：up to 21 days
Title
Single-dose Cmax
Description
Maximum Observed Plasma Concentration
Time Frame
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Title
Single-dose AUClast
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Title
Single-dose AUCtau
Description
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.
Time Frame
0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline up to 28 days after the last dose of study drug
Title
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
Description
Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion.
Time Frame
Baseline up to 28 days after the last dose of study drug
Title
Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Description
Pharmacokinetics of Maplirpacept
Time Frame
0, 1, 2, 4, 24, 72 hours post-dose up to Day8
Title
Multiple-dose Cmax (Maximum Observed Plasma Concentration)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Multiple-dose Ctrough (trough concentration)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Multiple-dose Rac (Accumulation Ratio)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
CL (Systemic Clearance)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Vss (Volume of Distribution at Steady State)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
t½ (Plasma Decay Half-Life)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Incidence and titers of anti-drug antibodies against TTI-622
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Incidence and titers of neutralizing antibodies against TTI-622
Description
Pharmacokinetics of Maplirpacept
Time Frame
Through study completion, up to 18 months
Title
Objective Response
Description
To assess the preliminary antitumor activity of Maplirpacept
Time Frame
Baseline to measured progressive disease, up to 18 months
Title
Time to Tumor Response (TTR)
Description
To assess the preliminary antitumor activity of Maplirpacept
Time Frame
Baseline to measured progressive disease, up to 18 months
Title
Duration of Response (DOR)
Description
To assess the preliminary antitumor activity of Maplirpacept
Time Frame
Baseline to measured progressive disease, up to 18 months
Title
Progression-Free Survival (PFS)
Description
To assess the preliminary antitumor activity of Maplirpacept
Time Frame
Baseline to measured progressive disease, up to 18 months
Title
Minimal Residual Disease (MRD)
Description
To assess the preliminary antitumor activity of Maplirpacept. Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria.
Time Frame
Baseline to measured progressive disease, up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4971010
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China
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