Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, As A Single Agent And In Combination With Either PF-06801591 Or Lenalidomide 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 : July 8, 2020
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 monotherapy IV or SC Drug: PF-06863135 + PF-06801591 Drug: PF-06863135 + lenalidomide 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
Allocation: Non-Randomized
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, AS A SINGLE AGENT AND IN COMBINATION WITH EITHER PF-06801591 OR LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : March 21, 2023
Estimated Study Completion Date : March 21, 2023

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 monotherapy IV or SC
PF-06863135 will be administered intravenously or subcutaneously.

Experimental: PF-06863135 + PF-06801591
BCMA-CD3 bispecific antibody + anti-PD-1
Drug: PF-06863135 + PF-06801591
PF-06863135 will be administered intravenously or subcutaneously.

Experimental: PF-06863135 + lenalidomide
BCMA-CD3 bispecific antibody + lenalidomide
Drug: PF-06863135 + lenalidomide
PF-06863135 will be administered intravenously or subcutaneously.




Primary Outcome Measures :
  1. Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 21 or 28 days ]
    Number of participants with DLTs, which are typically Grade 3 or higher adverse events

  2. To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion [ Time Frame: From baseline and every 3-4 weeks through disease progression or study completion (approximately 2 years) ]
    Percentage of participants that have a best response of partial response or better using IMWG criteria

  3. To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion [ Time Frame: From start of response to end of response or study completion (approximately 2 years) ]
    Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria


Secondary Outcome Measures :
  1. To evaluate incidence of treatment emergent adverse events and laboratory abnormalities [ Time Frame: From baseline until end of study treatment or study completion (approximately 2 years) ]
    Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities

  2. To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation [ Time Frame: From baseline and every 3-4 weeks through disease progression or study completion (approximately 2 years) ]
    Percentage of participants that have a best response of partial response or better using IMWG criteria

  3. To evaluate anti-myeloma activity by time to event endpoints [ Time Frame: From baseline through time to event on study or study completion (approximately 2 years) ]
    Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)

  4. To evaluate anti-myeloma activity by duration of event endpoints [ Time Frame: From start of event endpoint to end of event endpoint or study completion (approximately 2 years) ]
    Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria

  5. Impact of treatment on systemic soluble immune factors [ Time Frame: 9 months on treatment ]
    Pre and post dose quantification of soluble cytokines in serum.

  6. Maximum plasma concentration (Cmax) of PF-06863135 [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks) ]
    Peak concentration of PF-06863135 during first cycle

  7. Trough serum concentrations of PF-06863135 and PF-06801591 [ Time Frame: From start of treatment until end of treatment or study completion (approximately 2 years) ]
    Trough serum concentrations of PF-06863135 and PF-06801591 at selected cycles

  8. Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135 [ Time Frame: From start of treatment until end of treatment or study completion (approximately 2 years) ]
    AUC of PF-06863135 will be calculated at selected cycles

  9. Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135 and PF-06801591 when combined with PF-06863135 [ Time Frame: From baseline and scheduled timepoints post dose through study completion (approximately 2 years) ]
    Number of participants with the presence of anti-PF-06863135 antibodies and PF-06801591 when combined with PF-06863135



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:

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 2 (unless due to bone pain)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

Exclusion Criteria:

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication
  • Current requirement for chronic blood product support

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
Show Show 32 study locations
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    
Other Study ID Numbers: C1071001
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
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
PF-06801591
lenalidomide
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
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents