A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer and Multiple Myeloma.

Study Purpose

The purpose of this study is to test the safety and efficacy of ANV419 (single agent) in patients with relapsed/refractory advanced solid tumors and multiple myeloma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Ability of the patient or legal guardian to understand the purpose of the study, provide signed and dated informed consent from the patient prior to performing any protocol-related procedures (including Screening evaluations), and be able and willing to comply with the study procedures.
  • - Male or female aged ≥ 18 years.
  • - Advanced solid tumors with evidence of progressive disease as per RECIST no longer than 3 months before Informed Consent form (ICF) signature, without any subsequent curative intent treatment.
  • - Histologically confirmed relapsed/refractory advanced solid tumor, progressing after at least one line of treatment for advanced or metastatic disease, or for multiple myeloma, progressing during or after at least three lines of treatment including an.
  • - IMiD, a proteasome inhibitor and a aCD38 agent.
  • - Patients with multiple myeloma (MM) must have measurable disease (non-secretory MM must have measurable active lesions in PET) and have had evidence of a previous response (PR or better) to lenalidomide or daratumumab according to IMWG2016.
  • - No additional established line of on-label treatment is available or there is a contraindication for the indicated labelled therapies as deemed by the Investigator.
  • - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • - Adequate pulmonary, cardiovascular, hematological, liver and renal function, per Investigator judgment.
  • - All acute toxic effects, of any prior anticancer therapy (e.g., radiotherapy, chemotherapy, or surgical procedures) must have resolved to CTCAE v5.0 grade ≤1 (except alopecia [any grade] or fatigue [up to grade 2 allowed]).
  • - Negative serum pregnancy test at screening and a negative (urine or serum) pregnancy test within 7 days prior to study day 1 in women of childbearing potential and women <12 months after menopause.
  • - Women 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 until 6 months after the last dose of study treatment.
They must also agree to not donate eggs (ova, oocytes) during the same timeframe.
  • - All men with childbearing potential partners must agree to use highly effective methods of contraception and barrier contraception (condom) during the treatment period and for 6 months after the last dose of study treatment.
They must also agree to not donate sperm during the same timeframe.
  • - Availability and willingness of patients to obtain a baseline and on treatment biopsy of the tumor.
Available archived biopsies (frozen or formalin fixed) may serve as baseline specimens, in patients who have residual tumor masses which can only be accessed with significant risk.

Exclusion Criteria:

  • - Symptomatic central nervous system (CNS) metastases.
Definitively treated CNS metastases (e.g., radiotherapy) stable for at least 6 weeks prior to Day 1 of study drug administration are acceptable.
  • - Participants with an active second malignancy.
Patients with precancerous lesions, concomitant early stages of prostate or breast cancer not requiring active treatment (past conditions currently resolved > 3 years prior to Screening are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable.
  • - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus, history of relevant pulmonary disorders, (e.g., severe bronchospasm, obstructive pulmonary disease), hyperthyroidism due to thyroiditis and known autoimmune diseases or other disease with ongoing fibrosis.
Stable vitiligo, autoimmune thyroiditis, and preexisting treated type 1 diabetes are acceptable and are not exclusion criteria.
  • - Significant cardiovascular/cerebrovascular disease, including myocardial infarction or transient ischemic attack (TIA) within 6 months prior to Day 1 of study drug administration.
  • - Active or uncontrolled infections requiring systemic antibiotics within one week (7 days) preceding Day 1 of treatment.
  • - Hemoglobin (Hb) <9 g/dL, transfusion of red blood cells allowed to reach threshold target.
  • - Neutrophils <1500 /mm3.
  • - Platelets <100000/mm3.
  • - Liver: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5xULN, if due to liver metastasis or primary liver cancer, AST or ALT >5x ULN.
  • - Total bilirubin > upper limit of normal (ULN) (in documented Gilbert's syndrome, direct bilirubin > ULN).
  • - International normalized ratio (INR) >1.5xULN.
  • - Serum creatinine > ULN and estimated creatinine clearance < 50 mL/min using the Cockcroft-Gault formula.
  • - Confirmed replicating human immunodeficiency virus (HIV) or confirmed active (replicative) hepatitis B virus or hepatitis C virus infection.
Patients with treated non-replicative disease are acceptable.
  • - Positivity for coronavirus disease 2019 (COVID-19) by naso-pharyngeal swab test.
Known serologic conversion is not an exclusion criterion.
  • - Evidence of hepatic cirrhosis with Child-Pugh score C.
  • - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding > Grade 2 that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
  • - Major surgery or significant traumatic injury <28 days prior to the first ANV419 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.
  • - Severe altered mental status.
  • - Pregnant or breastfeeding women.
  • - Known hypersensitivity to any of the components of ANV419 or its formulation.
  • - Concurrent therapy with any other investigational drug within one month prior to Day 1 of study drug administration.
  • - Active untreated immune-related endocrinopathies untreatable with replacement.
Prior immune related toxicities > Grade 3 after treatment with immunostimulatory drugs (e.g., colitis, neuropathy) that have not completely resolved.
  • - Chronic treatment with systemic immunosuppressive medications above 10 mg/day prednisolone equivalent for any reason.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04855929
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Anaveon AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Christoph Bucher
Principal Investigator Affiliation Anaveon AG
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Spain, Switzerland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumor, Adult Disease, Multiple Myeloma
Additional Details

The purpose of this First-in-Human, open-label, dose escalation study is to assess the initial safety and efficacy profile of ANV419 intravenous infusion in patients with advanced solid tumours and multiple myeloma. It will evaluate the safety and tolerability of ANV419 alone and, the safest and best dose of ANV419 when used alone.

Arms & Interventions

Arms

Experimental: ANV419 single agent

Interventions

Drug: - ANV419

ANV419 administered by intravenous (IV) infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Vall d'Hebrón, Barcelona, Spain

Status

Recruiting

Address

Hospital Vall d'Hebrón

Barcelona, ,

Madrid, Spain

Status

Recruiting

Address

START Madrid, Hospital Universitario HM Sanchinarro

Madrid, ,

University Hospital Basel, Basel, Switzerland

Status

Recruiting

Address

University Hospital Basel

Basel, ,

Cantonal Hospital St.Gallen, Saint-Gall, Switzerland

Status

Recruiting

Address

Cantonal Hospital St.Gallen

Saint-Gall, ,

Royal Marsden Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Marsden Hospital

London, ,