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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 HEMATOLOGIC MALIGNANCIES

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Complete

Nov. 02, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Relapsed or refractory hematologic malignancies

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

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

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)

+81-23-628-5840

Sept. 06, 2022

No

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.

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