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Multiple MyelomaPhase 1NCT04671251

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

A Phase 1 study testing AEVI-007 in people with Multiple Myeloma, run by Avalo Therapeutics, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
AEVI-007
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
7 sitesUnited States
Study dates
15 Dec 2020to 30 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • If applicable, the subject has undergone prior autologous hematopoietic stem cell transplantation more than 100 days prior to the Screening Visit.
  • 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.
  • Subject has provided written informed consent for this study.

Who cannot join

  • 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.
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  • 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.
  • Subject has psychiatric, substance abuse or social conditions that would interfere with the subject's participation or cooperation with the requirements of the trial.
  • Subject has known hypersensitivity to any of the components of AEVI-007.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Florida Cancer Specialists

    Lake Mary, Florida, 32746

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • James R. Berenson, MD., Inc.

    West Hollywood, California, 90069

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, Dose-Escalation Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

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.

Read the detailed description

This was a multicenter, open-label, dose-escalation, sequential groups Phase 1b clinical study in subjects with R/R multiple myeloma. The study utilized a "3+3" design. Three subjects were enrolled at each dose, starting with the initial dose of 4 mg/kg. If there were no DLTs, escalation to the next cohort took place. If there was 1 DLT, then the cohort was to be expanded to 6. If there were no further DLTs, then escalation to the next dose took place. If there were 2 DLTs in the initial 3 subjects, or 2 in the expanded cohort of 6 subjects, then the maximally tolerated dose (MTD) had been exceeded and dose escalation stopped. The dose prior to the dose where DLT was observed was then the RP2D. To allow safety assessment, the dosing of subjects within each dose level was staggered, with at least 24 hours between each subject.

Being tested
AEVI-007
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AEVI-007Drug

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

Study groups in NCT04671251
Study groupRoleWhat they receive
AEVI-007ExperimentalOpen-label, dose-escalation, single-arm
Receives: Drug: AEVI-007

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose

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

    Measured: Cohorts 1-3 will take approximately 4-5 months

Secondary outcomes (16)

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Approximately 9 months

  2. Incidence of Clinically Significant Changes in Clinical Laboratory Results

    Measured: Approximately 9 months

  3. Incidence of Clinically Significant Changes in Vital Signs

    Measured: Approximately 9 months

  4. Incidence of Clinically Significant Changes in Electrocardiogram Recordings

    Measured: Approximately 9 months

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

    Measured: Approximately 9 months

  6. Incidence of Clinically Significant Changes in Physical Examination Findings

    Measured: Approximately 9 months

  7. Maximum Observed Concentration of AEVI-007

    Measured: Approximately 9 months

  8. Apparent Terminal Half-Life of AEVI-007

    Measured: Approximately 9 months

  9. Clearance of AEVI-007

    Measured: Approximately 9 months

  10. Volume of Distribution of AEVI-007

    Measured: Approximately 9 months

  11. Area Under the Concentration-Time Curve From Time 0 to Time t of AEVI-007

    Measured: Approximately 9 months

  12. Anti-myeloma activity

    To assess the anti-myeloma activity of AEVI-007 based on International Myeloma Working Group (IMWG) criteria for response

    Measured: Approximately 9 months

  13. Determination of ADAs

    To determine the incidence of anti-drug antibodies to AEVI-007.

    Measured: Approximately 9 months

  14. Time to Response (TTR)

    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.

    Measured: Approximately 9 months

  15. Progression Free Survival (PFS)

    Defined as the duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first

    Measured: Approximately 9 months

  16. Duration of Response

    Defined as the duration from the first observation of PR to the time of disease progression, with deaths from causes other than progression censored

    Measured: Approximately 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671251
Sponsor's protocol ID
AEVI-007-MM-101
Status last verified
Feb 2024
First submitted
1 Dec 2020
Last updated
29 Feb 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AEVI-007 in people with Multiple Myeloma, run by Avalo Therapeutics, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (time frame: Cohorts 1-3 will take approximately 4-5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04671251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.

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