Clinical trial NCT05896774: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin Lymphoma
Multiple Myeloma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicity (DLT)
timeFrame: Cycle 1：up to 21 days
measure: Single-dose Cmax
timeFrame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
measure: Single-dose AUClast
timeFrame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
measure: Single-dose AUCtau
timeFrame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Secondary outcomes:
measure: 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
timeFrame: Baseline up to 28 days after the last dose of study drug
measure: 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
timeFrame: Baseline up to 28 days after the last dose of study drug
measure: Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
timeFrame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day8
measure: Multiple-dose Cmax (Maximum Observed Plasma Concentration)
timeFrame: Through study completion, up to 18 months
measure: Multiple-dose Ctrough (trough concentration)
timeFrame: Through study completion, up to 18 months
measure: Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)
timeFrame: Through study completion, up to 18 months
measure: Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)
timeFrame: Through study completion, up to 18 months
measure: Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)
timeFrame: Through study completion, up to 18 months
measure: Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)
timeFrame: Through study completion, up to 18 months
measure: Multiple-dose Rac (Accumulation Ratio)
timeFrame: Through study completion, up to 18 months
measure: CL (Systemic Clearance)
timeFrame: Through study completion, up to 18 months
measure: Vss (Volume of Distribution at Steady State)
timeFrame: Through study completion, up to 18 months
measure: t½ (Plasma Decay Half-Life)
timeFrame: Through study completion, up to 18 months
measure: AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)
timeFrame: Through study completion, up to 18 months
measure: Incidence and titers of anti-drug antibodies against TTI-622
timeFrame: Through study completion, up to 18 months
measure: Incidence and titers of neutralizing antibodies against TTI-622
timeFrame: Through study completion, up to 18 months
measure: Objective Response
timeFrame: Baseline to measured progressive disease, up to 18 months
measure: Time to Tumor Response (TTR)
timeFrame: Baseline to measured progressive disease, up to 18 months
measure: Duration of Response (DOR)
timeFrame: Baseline to measured progressive disease, up to 18 months
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to measured progressive disease, up to 18 months
measure: Minimal Residual Disease (MRD)
timeFrame: Baseline to measured progressive disease, up to 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: