Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03269136
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PF-06863135 Phase 1

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : October 26, 2021
Estimated Study Completion Date : April 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: PF-06863135
BCMA-CD3 bispecific antibody
Drug: PF-06863135
PF 06863135 will be administered intravenously. Increases in dose will continue until MTD is determined.

Drug: PF-06863135
PF-06863135 will be administered subcutaneously. Increases in dose will continue until MTD is determined.




Primary Outcome Measures :
  1. Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 21 days ]
    First cycle DLTs during dose escalation in order to determine the maximum tolerated dose (MTD).

  2. Dose Expansion: To assess clinical efficacy at RP2D. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Overall response rate

  3. Dose Expansion: To assess clinical efficacy at RP2D. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Duration of response.


Secondary Outcome Measures :
  1. To evaluate incidence of treatment emergent adverse events and laboratory abnormalities [ Time Frame: From baseline until 1 month after end of treatment ]
    Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities

  2. To evaluate anti myeloma activity. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Overall response rate

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Cmax will be calculated for PF-06863135.

  4. Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose of PF-06863135 will be calculated.

  5. Incidence of anti-drug antibodies [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Number of participants with the presence of anti-PF-06863135 antibodies.

  6. Impact of PF 06863135 on systemic soluble immune factors. [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Pre and post dose quantification of soluble cytokines in serum.

  7. To evaluate anti myeloma activity. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Time to event endpoints including duration of response.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269136


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Layout table for location information
United States, Illinois
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy Recruiting
Chicago, Illinois, United States, 60637
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Louisiana
Ochsner Clinic Foundation Research Pharmacy Not yet recruiting
New Orleans, Louisiana, United States, 70121
Ochsner Clinic Foundation Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Adult Bone Marrow Transplant Clinic Recruiting
Durham, North Carolina, United States, 27705
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Investigational Chemotherapy Service Recruiting
Durham, North Carolina, United States, 27710
United States, Tennessee
Henry-Joyce Cancer Clinic Recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt Oncology Pharmacy Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Investigational Drug Services, Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03269136     History of Changes
Other Study ID Numbers: C1071001
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Multiple Myeloma
relapse/ refractory multiple myeloma
bispecific antibody
bispecific
BCMA
BCMA- CD3 bispecific
Phase 1
PF-06863135

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs