NCT05567887CompletedPhase 1
A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies
A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TTI-622 (PF-07901801), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED OR REFRACTORY LYMPHOMA
Source: ClinicalTrials.gov · Last updated 6 Nov 2024
Brief summary (registry, in English)
The purpose of this clinical trial is to learn about how safe and tolerable is the study medicine (called maplirpacept (PF-07901801)) when taken for the treatment of lymphoma or multiple myeloma (a type of cancer that affects your body's infection-fighting cells, lymphocytes or plasma cell). This study is seeking participants who: * are 18 years of age or older * have worsening and difficult to manage type of lymphoma or multiple myeloma * Have adequately functioning organs * are not on long term use of steroids which are given either by mouth or as shots * have no major heart related disease etc. All participants in this study will receive maplirpacept (PF-07901801) as an IV infusion (given directly into a vein) at the study clinic every week. Participants will continue to receive maplirpacept (PF-07901801) until their progress of cancer worsens or the participants do not wish to take the study medicine. The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine maplirpacept (PF-07901801), is safe and can be given to Japanese people.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 2 Nov 2022
- Primary completion date
- 2 Oct 2024
- Lead sponsor
- Pfizer
- Diseases
- Multiple myeloma
- NCT number
- NCT05567887
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 7
- From 2 Nov 2022 to the primary completion date, 2 Oct 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Antiplatelet/anticoagulant agents within 14 days before planned start of study treatment
- Patients sustaining major surgery at least 4 weeks prior to study enrollment
- Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment
- Prior anti-CD47 and anti-Signal Regulatory Protein alpha therapy
Other illness
- Known, current central nervous system or interstitial lung disease involvement
- History of hemolytic anemia or positive direct antiglobulin test or active bleeding disorder
- Significant cardiovascular disease
- Other significant medical condition unrelated to the primary malignancy
- Active, uncontrolled bacterial, fungal, or viral infection
Other
- Investigator site staff directly involved in the conduct of the study and their family members
Who the study is looking for
- Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's) or multiple myeloma
- Disease must have progressed with standard anticancer therapies
- measurable disease
- Capable of giving signed informed consent
- Eastern cooperative oncology group performance status 0 or 1
- Adequate organ functions
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Japanese Foundation for Cancer Research Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.