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 |
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.
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.
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
10
sites
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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5700 South Maryland Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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