A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
NCT ID: NCT02663518
Last Updated: 2024-05-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
249 participants
INTERVENTIONAL
2016-01-28
2022-11-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-07901800 (TTI-621) Escalation Phase - R/R Lymphoma
The Escalation Phase will include multiple doses of PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Indolent B-Cell Lymphoma
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Aggressive B-Cell Lymphoma
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
T-Cell Lymphoma
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Hodgkin Lymphoma
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Chronic Lymphocytic Leukemia
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Multiple Myeloma
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Acute Myeloid Leukemia
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Myelodysplastic Syndrome
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Myeloproliferative Neoplasms
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Small Cell Lung Cancer
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Rituximab Combination
Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Rituximab for CD20 positive malignancies
PF-07901800 (TTI-621) plus Rituximab
Combination therapy
Nivolumab Combination
Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Nivolumab for Hodgkin Lymphoma
PF-07901800 (TTI-621) plus Nivolumab
Combination therapy
Cutaneous T-Cell Lymphoma (CTCL)
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Peripheral T-Cell Lymphoma (PTCL)
Monotherapy expansion cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Part 4: Cutaneous T-Cell Lymphoma (CTCL)
Monotherapy expansion Part 4 (Dose Optimization) cohort with PF-07901800 (TTI-621)
PF-0791800 (TTI-621)
Monotherapy
Interventions
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PF-0791800 (TTI-621)
Monotherapy
PF-07901800 (TTI-621) plus Rituximab
Combination therapy
PF-07901800 (TTI-621) plus Nivolumab
Combination therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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City of Hope National Medical Center
Duarte, California, United States
City of Hope
Duarte, California, United States
Freidenrich Center for Translational Research (CTRU)
Palo Alto, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian/St.Luke's Medical Center
Denver, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Covance Biorepository
Greenfield, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Hackensack Meridian Health John Theurer Cancer Center
Hackensack, New Jersey, United States
Hackensack UMC
Hackensack, New Jersey, United States
The John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
NYU Investigational Pharmacy
New York, New York, United States
NYU Langone Health (Tisch Hospital)
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Clinical Trails Office
New York, New York, United States
Columbia Univeristy
New York, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York, New York, United States
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York, New York, United States
Columbia University Medical Center.
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University-Research Pharmacy Services
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pittsburgh Medical Center Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Centennial Medical Center
Nashville, Tennessee, United States
Sarah Cannon Research Institute (Pharmacy)
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Myriad RMB Inc
Austin, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Cancer Prevention Center
Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Melanoma and Skin Clinic
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Fairmont Medical Building, Suite 810
Vancouver, B.C., Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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Marks JA, Wang X, Fenu EM, Bagg A, Lai C. TP53 in AML and MDS: The new (old) kid on the block. Blood Rev. 2023 Jul;60:101055. doi: 10.1016/j.blre.2023.101055. Epub 2023 Feb 14.
Ansell SM, Maris MB, Lesokhin AM, Chen RW, Flinn IW, Sawas A, Minden MD, Villa D, Percival MM, Advani AS, Foran JM, Horwitz SM, Mei MG, Zain J, Savage KJ, Querfeld C, Akilov OE, Johnson LDS, Catalano T, Petrova PS, Uger RA, Sievers EL, Milea A, Roberge K, Shou Y, O'Connor OA. Phase I Study of the CD47 Blocker TTI-621 in Patients with Relapsed or Refractory Hematologic Malignancies. Clin Cancer Res. 2021 Apr 15;27(8):2190-2199. doi: 10.1158/1078-0432.CCR-20-3706. Epub 2021 Jan 15.
Johnson LDS, Banerjee S, Kruglov O, Viller NN, Horwitz SM, Lesokhin A, Zain J, Querfeld C, Chen R, Okada C, Sawas A, O'Connor OA, Sievers EL, Shou Y, Uger RA, Wong M, Akilov OE. Targeting CD47 in Sezary syndrome with SIRPalphaFc. Blood Adv. 2019 Apr 9;3(7):1145-1153. doi: 10.1182/bloodadvances.2018030577.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4961001
Identifier Type: OTHER
Identifier Source: secondary_id
TTI-621-01
Identifier Type: -
Identifier Source: org_study_id
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