Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

NCT04671251 | Completed Phase 1 FDA Drug

• 1 other identifier: AEVI-007-MM-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 7

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Recommended Phase 2 Dose

  Identify the recommended Phase 2 dose based on safety, pharmacokinetics and pharmacodynamics observed in this Phase 1b study.

  Cohorts 1-3 will take approximately 4-5 months

Secondary Outcomes (16)

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Approximately 9 months

• Incidence of Clinically Significant Changes in Clinical Laboratory Results

  Approximately 9 months

• Incidence of Clinically Significant Changes in Vital Signs

  Approximately 9 months

• Incidence of Clinically Significant Changes in Electrocardiogram Recordings

  Approximately 9 months

• Incidence of Clinically Significant Changes to Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score

  Approximately 9 months

Study Arms (1)

AEVI-007

EXPERIMENTAL

Open-label, dose-escalation, single-arm

Drug: AEVI-007

Interventions

AEVI-007 DRUG

50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection.

AEVI-007

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has active R/R multiple myeloma.
• 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
• 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.
• Subject has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Subject is \> 18 years of age.
• 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

You may not qualify if:

• Subject has currently active infection requiring use of systemic antimicrobial therapy.
• 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).
• Subject has hyperviscosity syndrome.
• Subject has central nervous system involvement by myeloma, including leptomeningeal involvement.
• Subject is judged to be at risk for impending fracture.
• Subject has known amyloidosis or POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes) syndrome.
• Subject had another malignancy within 1 year of study entry with high probability of recurrence.
• Subject is pregnant or lactating.
• 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.
• Subject has undergone major surgery or trauma within 4 weeks of study entry.
• Subject has been previously treated with an anti IL 18 antibody.
• 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.
• 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.
• Subject has had a prior allogeneic transplant.
• 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.

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (7)

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

James R. Berenson, MD., Inc.

West Hollywood, California, 90069, United States

Location

Florida Cancer Specialists

Lake Mary, Florida, 32746, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Manish Patel, MD

  Florida Cancer Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 17, 2020
• Study Start: December 15, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)