A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

NCT05641324 | Terminated Phase 1

• 1 other identifier: ANV419-102
• Study Type: interventional
• Target: 4
• Locations: 5 countries
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab.

Conditions

Multiple Myeloma; Relapsed Cancer; Refractory Multiple Myeloma; Adult Disease; Hematologic Diseases

Keywords

IL-2; ANV419; Cancer; Multiple Myeloma; OMNIA

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 monotherapy

  Day 1 up to 12 months

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 in combination with lenalidomide plus low-dose dexamethasone

  Day 1 up to 12 months

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 in combination with daratumumab

  Day 1 up to 12 months

Secondary Outcomes (11)

• Serum concentration of ANV419 in blood

  Day 1 up to 12 months

• Impact of ANV419 on the expression of markers of PBMC lineage in blood

  Day 1 up to 12 months

• Levels of specific anti-ANV419 antibodies in blood

  Day 1 up to 12 months

• Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 monotherapy

  Day 1 up to 12 months

• Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 in combination with lenalidomide plus low-dose dexamethasone

  Day 1 up to 12 months

Study Arms (4)

ANV419 single agent, dose 1, Q2W

EXPERIMENTAL

Drug: ANV419

ANV419 single agent, dose 2, Q2W

EXPERIMENTAL

Drug: ANV419

ANV419 Q2W + Lenalidomide plus low-dose dexamethasone

EXPERIMENTAL

Drug: ANV419; Drug: Lenalidomide with low-dose dexamethasone

ANV419 Q2W + Daratumumab

EXPERIMENTAL

Drug: ANV419; Drug: Daratumumab

Interventions

ANV419 DRUG

ANV419 administered by intravenous (IV) infusion

ANV419 Q2W + Daratumumab; ANV419 Q2W + Lenalidomide plus low-dose dexamethasone; ANV419 single agent, dose 1, Q2W; ANV419 single agent, dose 2, Q2W

Lenalidomide with low-dose dexamethasone DRUG

Lenalidomide and dexamethasone administered orally

ANV419 Q2W + Lenalidomide plus low-dose dexamethasone

Daratumumab DRUG

Daratumumab administered by subcutaneous injection

ANV419 Q2W + Daratumumab

Eligibility Criteria

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

You may qualify if:

• Must provide written informed consent for the study;
• Must be able to comply with the Protocol as judged by the Investigator;
• Are ≥18 years of age on the day of signing informed consent
• Have been diagnosed with symptomatic MM per CRAB (calcium elevation, renal dysfunction, anemia, bone disease) criteria;
• Have had evidence of a response (defined as partial response \[PR\] or better according to IMWG response criteria \[Appendix C\]) during previous treatment;
• Have undergone treatment with ASCT or have progressed from at least 2 other prior treatment lines (including an immunomodulatory imide drug and/or daratumumab);
• Have relapsed on, or been refractory or intolerant to, the last treatment line, and have measurable disease evaluated by monoclonal proteins (M-proteins) and/or free light chains according to IMWG response criteria (Appendix C). Non-secretory MM must have measurable, active lesions by positron emission tomography;
• Have a performance status of 0 to 2 on the ECOG Performance Status;
• Have adequate organ functions;
• Willing to undergo bone marrow biopsies if determined clinically feasible based on the Investigator's assessment;
• Are eligible for treatment with daratumumab;
• Are eligible for treatment or re-treatment with lenalidomide (as per the European Medicines Agency labeling criteria);
• Are eligible for prophylaxis for thromboembolism per IMWG response criteria;
• Female patients of childbearing potential must have a negative serum pregnancy test at screening and a negative (urine or serum) pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and must be negative for the patient to be eligible;
• Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oocytes) during the same timeframe; and

You may not qualify if:

• Have received an investigational agent (including investigational device) \<4 weeks or 5 half-lives prior to study Cycle 1 Day 1, whichever is longer;
• Have hypersensitivity to any components of ANV419 (IL-2, anti-IL-2 mAb) or its formulation (L-histidine, L-histidine HCl, sucrose, polysorbate 80, water; see Appendix D);
• Have hypersensitivity to lenalidomide, dexamethasone, daratumumab, or any of their excipients;
• Have received daratumumab \<3 months prior to the signing of informed consent;
• Have received any drugs that may be active for MM \<3 weeks prior to the signing of informed consent;
• Have received high-dose corticosteroids (≥1 mg/kg) ≤3 weeks prior to the signing of informed consent;
• Have received radiotherapy ≤1 month prior to the signing of informed consent;
• Have had an autologous hematopoietic cell transplant (HCT) within the last 6 months;
• Have had a previous allogeneic HCT;
• Have had major surgery \<4 weeks prior to the signing of informed consent or anticipate the need for major surgery during treatment; Note: Major surgery is defined as any surgery requiring entrance into a body cavity (eg, chest, abdomen, or brain), organ removal, normal anatomy alteration, or joint replacement. Minor surgery is defined as any surgery in which skin, mucosa, or connective tissue sections are altered (eg, biopsy, cataract, endoscopic procedures, etc).
• Have clinical signs of meningeal involvement of MM;
• Have a history of a past or current malignancy prior to screening, except for:
• Cervical carcinoma of Stage 1B or less;
• Non-invasive basal cell or squamous cell skin carcinoma requiring treatment; or
• Current or past malignancy with a complete response for \<3 years at screening.

Sponsors & Collaborators

• Anaveon AG: lead

Study Sites (11)

Vejle Hospital

Vejle, Denmark

Location

Institut Paoli-Calmettes

Marseille, France

Location

CHU de Nantes - Hôtel-Dieu

Nantes, France

Location

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, France

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Location

Inselspital, Universitätsspital Bern

Bern, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence; Disease; Hematologic Diseases; Neoplasms

Interventions

Lenalidomide; Dexamethasone; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Eduard Gasal, MD

  Anaveon AG

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: February 10, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); DK (1); FR (3); CH (2); ES (4)