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.

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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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

249

Study ID:

NCT02663518

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 29 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
City of Hope
Duarte California, 91010, United States
Freidenrich Center for Translational Research (CTRU)
Palo Alto California, 94304, United States
Stanford Cancer Institute
Palo Alto California, 94304, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Presbyterian/St.Luke's Medical Center
Denver Colorado, 80218, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Covance Biorepository
Greenfield Indiana, 46140, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Hackensack Meridian Health John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
Hackensack UMC
Hackensack New Jersey, 07601, United States
The John Theurer Cancer Center at Hackensack UMC
Hackensack New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
NYU Investigational Pharmacy
New York New York, 10016, United States
NYU Langone Health (Tisch Hospital)
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center-Clinical Trails Office
New York New York, 10017, United States
Columbia Univeristy
New York New York, 10019, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York New York, 10021, United States
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York New York, 10022, United States
Columbia University Medical Center.
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health & Science University-Research Pharmacy Services
Portland Oregon, 97239, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Oregon Health and Sciences University
Portland Oregon, 97239, United States
University of Pittsburgh Medical Center Presbyterian Shadyside
Pittsburgh Pennsylvania, 15213, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15237, United States
Centennial Medical Center
Nashville Tennessee, 37203, United States
Sarah Cannon Research Institute (Pharmacy)
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Myriad RMB Inc
Austin Texas, 78759, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Texas MD Anderson Cancer Center, Cancer Prevention Center
Houston Texas, 77030, United States
University of Texas MD Anderson Cancer Center, Melanoma and Skin Clinic
Houston Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington - Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Fairmont Medical Building, Suite 810
Vancouver B.C., V5Z1H, Canada
British Columbia Cancer Agency
Vancouver British Columbia, V5Z 1, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

249

Study ID:

NCT02663518

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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