A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies

JRCT ID: jRCT2021220030

Registered date:21/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or refractory hematologic malignancies
• Date of first enrollment: 02/11/2022
• Target sample size: 7
• Study type: Interventional

Intervention(s)

Drug: maplirpacept (PF-07901801)
Other Name: TTI-622

Outcome(s)

Primary Outcome

Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma [ Time Frame: up to 21 days ]
Number of participants with DLTs

Secondary Outcome

1.Number of adverse events as characterized by type [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

2.Number of adverse events as characterized by frequency [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

3.Number of adverse events as characterized by severity [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

4.Number of adverse events as characterized by timing [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

5.Number of adverse events as characterized by relationship to maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

6.Number of adverse events as characterized by seriousness [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

7.Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

8.Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

9.Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

10.Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing [ Time Frame: Through study completion, up to 18 months ]
overall safety profile of maplirpacept (PF-07901801)

11. Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma [ Time Frame: Through study completion, up to 18 monghs ]
overll safety profile of maplirpacept (PF-07901801)

12.maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

13.time to maximum concentration,ss of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

14.area under the curve last,ss of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

15.area under the curve tau,ss of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

16.time to maximum concentration of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

17.trough concentration of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

18.area under the curve last of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

19.clearance of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

20.area under the curve tau of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

21.volume of distribution at steady-state of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

22.area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

23.area under the curve inf of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

24.terminal elimination half-life off maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

25.maximum observed concentration of maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
pharmacokinetics of maplirpacept (PF-07901801)

26.Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
immunogenicity of maplirpacept (PF-07901801)

27.Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801) [ Time Frame: Through study completion, up to 18 months ]
immunogenicity of maplirpacept (PF-07901801)

28.overall response rate [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months ]
preliminary antitumor activity of maplirpacept (PF-07901801)

29.progression free survival [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months ]
preliminary antitumor activity of maplirpacept (PF-07901801)

30.time to response [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months ]
preliminary antitumor activity of maplirpacept (PF-07901801)

31.duration of response [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months ]
preliminary antitumor activity of maplirpacept (PF-07901801)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion Criteria:
* 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

Exclude criteria

Exclusion Criteria:
*Known, current central nervous system or interstitial lung disease involvement
*History of hemolytic anemia or positive direct antiglobulin test or active bleeding disorder
*Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent
*Significant cardiovascular disease
*Other significant medical condition unrelated to the primary malignancy
*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
*Active, uncontrolled bacterial, fungal, or viral infection
*Investigator site staff directly involved in the conduct of the study and their family members

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05567887