A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer and Multiple Myeloma. (ANV419-001)
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|ClinicalTrials.gov Identifier: NCT04855929|
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : March 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor Adult Disease Multiple Myeloma||Drug: ANV419||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ANV419 Single Agent First in Human Study Phase 1: Open-label, Dose Escalation Study in Patients With Relapsed/Refractory Advanced Solid Tumors and Multiple Myeloma|
|Actual Study Start Date :||May 25, 2021|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||December 2024|
|Experimental: ANV419 single agent||
ANV419 administered by intravenous (IV) infusion
- Number of Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 14 ]
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to 12 months ]
- Recommended Phase 2 Dose [ Time Frame: Day 1 to Day 28 ]
- Objective response rate (ORR) assessed by RECIST v1.1 and iRECIST for solid tumors and IMWG2016 for multiple myeloma [ Time Frame: Day 1 up to 12 months ]
- Plasma concentration of ANV419 in blood [ Time Frame: Day 1 up to 12 months ]
- Impact of ANV419 on the expression of markers of PBMC lineage in blood [ Time Frame: Day 1 up to 12 months ]
- Levels of specific anti-ANV419 antibodies in blood [ Time Frame: Day 1 up to 12 months ]
- Disease control according to RECIST v1.1 and iRECIST or IMWG2016 [ Time Frame: Day 1 up to 12 months ]
- Progression-free survival (PFS) according to RECIST v1.1 and iRECIST or IMWG2016 [ Time Frame: Day 1 up to 12 months ]
- Duration of response (DOR) according to RECIST v1.1 and iRECIST or IMWG2016 [ Time Frame: Day 1 up to 12 months ]
- Overall survival (OS) [ Time Frame: Day 1 up to 12 months ]
- Quality of life assessed with European Quality of Life Five Dimensions (EQ-5D-5L) [ Time Frame: Day 1 up to 12 months ]
- Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Day 1 up to 12 months ]
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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): NCT04855929
|Contact: Silvio Costanzofirstname.lastname@example.org|
|Contact: Sangeeta Jethwa, MDemail@example.com|
|Hospital Vall d'Hebrón||Recruiting|
|START Madrid, Hospital Universitario HM Sanchinarro||Recruiting|
|University Hospital Basel||Recruiting|
|Cantonal Hospital St.Gallen||Recruiting|
|Royal Marsden Hospital||Recruiting|
|London, United Kingdom|
|Study Director:||Sangeeta Jethwa, MD||Anaveon AG|
|Responsible Party:||Anaveon AG|
|Other Study ID Numbers:||
|First Posted:||April 22, 2021 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases