Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, In Relapse/ Refractory Multiple Myeloma



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:November 29, 2017
End Date:February 13, 2022
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA)-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients
with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose
and select the recommended Phase 2 dose.

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety,
pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced
multiple myeloma who have relapsed from or are refractory to standard therapy. This two part
study will assess the safety and tolerability of increasing dose levels of PF-06863135 in
Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.

Inclusion Criteria:

- Patients with relapse/ refractory multiple myeloma

- Performance Status of 0- 2 (unless due to bone pain)

- Adequate bone marrow, kidney and liver function

Exclusion Criteria:

- History of active autoimmune disorders

- Active and clinically significant bacterial, fungal, or viral infection

- Major surgery within 4 weeks of study treatment start

- Radiation therapy within 2 weeks of study treatment start

- Less than 30 days since last dose of anti CD38 therapy, elotuzumab or other anti-CD319
therapy or less than 5 half-lives since last dose of previous systemic therapy.

- Stem cell transplant (autologous or allogeneic) within 100 days of study treatment
start
We found this trial at
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Nashville, Tennessee 37232
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
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Durham, NC
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Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
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Durham, NC
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Nashville, Tennessee 37232
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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