Multiple Myeloma Clinical Trial
A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
Summary
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
Full Description
This is a trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
TTI-621 (SIRPαFc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (anti phagocytic) signal to macrophages.
This trial will be conducted in 2 phases and 4 parts: Phase 1a Part 1 (escalation phase) and Phase 1b Parts 2-4 (expansion phase).
In the dose Escalation Phase (phase 1a Part 1), subjects with lymphoma will be enrolled in sequential dose cohorts to receive TTI-621 to characterize safety, tolerability, pharmacokinetics, and the maximum-tolerated dose (MTD).
In the Expansion Phase (phase 1b Parts 2-4), TTI-621 will be given to subjects with a variety of hematologic malignancies and selected solid tumors to further define safety and to characterize efficacy. In the Expansion Phase Part 2, the safety and efficacy of TTI-621 will also be assessed when it is given in combination with other anti-cancer drugs. The dose of TTI-621 to be delivered in the Expansion Phase Parts 2-3 of the study may be increased or decreased based on the subject's tolerability and on the subject's response to treatment.
In the phase 1b dose optimization of the study (Part 4), further dose escalation of TTI-621, beyond the dose determined during phase 1a dose escalation, will be pursued in patients with relapsed and/or refractory CTCL following a 3+3 escalation design and using a revised DLT criteria to further evaluate the safety and tolerability of TTI-621 at dose levels higher than the initially recommended phase 1b Parts 2-3.
Secondary objectives include further characterization of the pharmacokinetics, pharmacodynamics, and development of ADA; and to gain preliminary evidence of the anti-tumor activity of TTI-621 in subjects with a variety of hematologic malignancies and selected solid tumors. In addition, the safety of TTI-621 will be evaluated in combination with other anti-cancer agents.
Pfizer decided terminating this study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.
Eligibility Criteria
MAJOR ELIGIBILITY CRITERIA:
Phase 1a Escalation
• Histologically documented, measurable, advanced lymphomas, transfusion-independence
Phase 1b Expansion (Part 2 and 3) • Advanced malignancy: IBCL, ABCL, cHL, AML, ALL, MDS, MPN, SCLC, PTCL and CTCL; measurable disease who have relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporeal photochemotherapy (ECP) considered a systemic therapy. Local radiation and topical agents are not systemic therapies.
Phase 1b dose optimization (Part 4)
• Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome): Failed at least 2 prior systemic therapies for CTCL (Systemic therapy does not include local radiation therapy or topical agents); History of histologically documented diagnosis of CTCL stage IB to IVB
Inclusion Criteria (all subjects):
Advanced measurable malignancy with previously progressed on, or currently progressing on standard anticancer therapy or for whom no other approved conventional therapy exists
Eastern Cooperative Oncology Group (ECOG) 0-2
Adequate hematologic, hepatic, renal, and coagulation function; fresh or archived tumor tissue available for immunohistochemistry
Recovery from prior treatments and/or surgeries; no history of hemolytic anemia or bleeding diathesis.
AML M3 (French American British, FAB, classification) (i.e., acute promyelocytic leukemia [APL]) excluded
Exclusion Criteria:
Known current central nervous system disease involvement or untreated brain metastases
Allogeneic transplant within 30 days prior to the planned start of treatment or subjects with active graft-vs-host disease with the exception of Grade 1 skin involvement
History of hemolytic anemia or bleeding diathesis
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There are 29 Locations for this study
Duarte California, 91010, United States
Duarte California, 91010, United States
Palo Alto California, 94304, United States
Palo Alto California, 94304, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Jacksonville Florida, 32224, United States
Jacksonville Florida, 32224, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Greenfield Indiana, 46140, United States
Rochester Minnesota, 55905, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Middletown New Jersey, 07748, United States
Harrison New York, 10604, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10017, United States
New York New York, 10019, United States
New York New York, 10021, United States
New York New York, 10022, United States
New York New York, 10032, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15237, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78759, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Vancouver B.C., V5Z1H, Canada
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5G 2, Canada
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