Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1b Study of AEVI-007 in Subjects With Relapsed or 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: NCT04671251
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc ( Aevi Genomic Medicine, LLC, a Cerecor company )

Brief Summary:

This is a multicenter, open-label, dose-escalation Phase 1b study of AEVI-007 in subjects with relapsed or refractory Multiple Myeloma.

The objectives of the study are to evaluate the safety, pharmacokinetics and pharmacodynamics of AEVI-007.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: AEVI-007 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Dose-Escalation Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: AEVI-007 Drug: AEVI-007
50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection.




Primary Outcome Measures :
  1. Recommended Phase 2 Dose [ Time Frame: Cohorts 1-3 will take approximately 4-5 months ]
    Identify the recommended Phase 2 dose based on safety, pharmacokinetics and pharmacodynamics observed in this Phase 1b study.


Secondary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Approximately 9 months ]
  2. Incidence of Clinically Significant Changes in Clinical Laboratory Results [ Time Frame: Approximately 9 months ]
  3. Incidence of Clinically Significant Changes in Vital Signs [ Time Frame: Approximately 9 months ]
  4. Incidence of Clinically Significant Changes in Electrocardiogram Recordings [ Time Frame: Approximately 9 months ]
  5. Incidence of Clinically Significant Changes to Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score [ Time Frame: Approximately 9 months ]
  6. Incidence of Clinically Significant Changes in Physical Examination Findings [ Time Frame: Approximately 9 months ]
  7. Maximum Observed Concentration of AEVI-007 [ Time Frame: Approximately 9 months ]
  8. Apparent Terminal Half-Life of AEVI-007 [ Time Frame: Approximately 9 months ]
  9. Clearance of AEVI-007 [ Time Frame: Approximately 9 months ]
  10. Volume of Distribution of AEVI-007 [ Time Frame: Approximately 9 months ]
  11. Area Under the Concentration-Time Curve From Time 0 to Time t of AEVI-007 [ Time Frame: Approximately 9 months ]
  12. Anti-myeloma activity [ Time Frame: Approximately 9 months ]
    To assess the anti-myeloma activity of AEVI-007 based on International Myeloma Working Group (IMWG) criteria for response

  13. Determination of ADAs [ Time Frame: Approximately 9 months ]
    To determine the incidence of anti-drug antibodies to AEVI-007.

  14. Time to Response (TTR) [ Time Frame: Approximately 9 months ]
    Defined as the time from start of the treatment to the first observation of PR or better. TTR is restricted to only subjects with confirmed responses.

  15. Progression Free Survival (PFS) [ Time Frame: Approximately 9 months ]
    Defined as the duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first

  16. Duration of Response [ Time Frame: Approximately 9 months ]
    Defined as the duration from the first observation of PR to the time of disease progression, with deaths from causes other than progression censored



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:

  1. Subject has active R/R multiple myeloma.
  2. Subject has measurable myeloma based on any of the following:

    • Serum M-protein > 0.5 g/dL
    • Urine M-protein > 200 mg/24 hours
    • Serum free light chains > 10 mg/dL
    • Measurable plasmacytoma or extramedullary disease
  3. Subject has active myeloma despite prior therapy with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.

    Note: Subject must not be a candidate for regimens known to provide clinical benefit.

  4. Subject has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  5. Subject is > 18 years of age.
  6. Subject has adequate hematopoietic, renal and hepatic function, defined as:

    • Absolute neutrophil count > 1,000/μL; platelet count > 75,000/μL in patients with < 50% marrow involvement
    • Absolute neutrophil count > 750/μL; platelet count > 50,000/μL in patients with >50% marrow involvement
    • Serum creatinine < 2.5 mg/dL or calculated creatinine clearance of > 30 mL/min according to the Cockcroft-Gault equation
    • Aspartate transaminase/alanine transaminase ≤2.5× the upper limit of normal (ULN) and total bilirubin < 2× the ULN
  7. If applicable, the subject has undergone prior autologous hematopoietic stem cell transplantation more than 100 days prior to the Screening Visit.
  8. Female patients of childbearing potential who are heterosexually active and male patients with female sexual partners of childbearing potential must agree to use an effective method of contraception (eg, oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) or abstain from sexual activity during the study and for 220 days (5 half-lives) following the last dose of study medication, or to abstain from sexual intercourse for this duration of study participation. A woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as the absence of menstrual periods for 12 consecutive months.
  9. Subject has provided written informed consent for this study.

Exclusion Criteria:

  1. Subject has currently active infection requiring use of systemic antimicrobial therapy.
  2. Subject has received corticosteroids (>10 mg/daily prednisone or equivalent) or chemotherapy within 2 weeks of study drugs (4 weeks for nitrosourea, melphalan or monoclonal antibodies).
  3. Subject has hyperviscosity syndrome.
  4. Subject has central nervous system involvement by myeloma, including leptomeningeal involvement.
  5. Subject is judged to be at risk for impending fracture.
  6. Subject has known amyloidosis or POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes) syndrome.
  7. Subject had another malignancy within 1 year of study entry with high probability of recurrence.
  8. Subject is pregnant or lactating.
  9. Subject has a history of, or tests positive for, hepatitis B, untreated hepatitis C or human immunodeficiency virus (HIV). Subject with hepatitis C who has received a full course of anti-viral therapy or who is currently receiving anti-viral therapy with undetectable levels of hepatitis C RNA is eligible for the trial.
  10. Subject has undergone major surgery or trauma within 4 weeks of study entry.
  11. Subject has been previously treated with an anti IL 18 antibody.
  12. Subject is currently taking immunomodulatory drugs, including pharmacologic doses of systemic glucocorticoids (> 10 mg prednisone daily or equivalent), anti tumor necrosis factor alpha (TNFα) antibodies, anti-IL-17 antibodies, anti IL 12/23 antibodies, phosphodiesterase-4 (PDE-4) inhibitors, janus kinase (JAK) inhibitors, IL-6 inhibitors, rituximab, methotrexate, cyclosporine, mycophenolate.
  13. Subject with known active autoimmune disorders including, but not limited to, rheumatoid arthritis, lupus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis, ulcerative colitis, Crohn's disease, vasculitis, multiple sclerosis. Subjects with autoimmune endocrinopathies on stable doses of replacement hormone therapy are eligible for the trial.
  14. Subject has had a prior allogeneic transplant.
  15. Subject has New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), myocardial infarction or acute coronary syndrome within 6 months prior to the Screening Visit, ongoing angina pectoris, severe peripheral vascular disease, or any other concomitant medical disorder that might interfere with the subject's participation in the trial or interpretation of the study data.
  16. Subject has psychiatric, substance abuse or social conditions that would interfere with the subject's participation or cooperation with the requirements of the trial.
  17. Subject has known hypersensitivity to any of the components of AEVI-007.

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): NCT04671251


Contacts
Layout table for location contacts
Contact: H. Jeffrey Wilkins, MD 610-457-5095 jwilkins@cerecor.com

Locations
Layout table for location information
United States, California
University of California, Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
James R. Berenson, MD., Inc. Recruiting
West Hollywood, California, United States, 90069
United States, Florida
Florida Cancer Specialists Recruiting
Lake Mary, Florida, United States, 32746
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Maryland
American Oncology Partners of Maryland, PA Recruiting
Bethesda, Maryland, United States, 20817
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Wisconsin
Froedtert Hospital & the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Aevi Genomic Medicine, LLC, a Cerecor company
Layout table for additonal information
Responsible Party: Aevi Genomic Medicine, LLC, a Cerecor company
ClinicalTrials.gov Identifier: NCT04671251    
Other Study ID Numbers: AEVI-007-MM-101
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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