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A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Solid Tumors. (ANV419-001)

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ClinicalTrials.gov Identifier: NCT04855929
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Anaveon AG

Tracking Information
First Submitted Date  ICMJE April 15, 2021
First Posted Date  ICMJE April 22, 2021
Last Update Posted Date October 4, 2021
Actual Study Start Date  ICMJE May 25, 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
  • Phase I: Number of Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 14 ]
  • Phase I: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to 12 months ]
  • Phase I: Recommended Phase 2 Dose [ Time Frame: Day 1 to Day 28 ]
  • Phase II: Objective Response Rate (ORR) assessed by RECIST v1.1 [ Time Frame: Day 1 up to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
  • Phase I: Objective response rate (ORR) assessed by RECIST v1.1 and iRECIST [ Time Frame: Day 1 up to 12 months ]
  • Phase II: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events [ Time Frame: Day 1 up to 12 months ]
  • Phase II: Objective Response Rate (ORR) assessed by iRECIST [ 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 [ Time Frame: Day 1 up to 12 months ]
  • Progression-free survival (PFS) according to RECIST v1.1 and iRECIST [ Time Frame: Day 1 up to 12 months ]
  • Duration of response (DOR) according to RECIST v1.1 and iRECIST [ 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Solid Tumors.
Official Title  ICMJE ANV419 Single Agent (Parts A-C) or Combination (Part D) First in Human Study Phase 1/2: Open-label, Dose Escalation and Expansion Study in Patients With Relapsed/Refractory Advanced Solid Tumors.
Brief Summary The purpose of this study is to test the safety and efficacy of ANV419 (single agent and combination therapy) in patients with relapsed/refractory advanced solid tumors.
Detailed Description The purpose of this First-in-Human, open-label, dose escalation and expansion study is to assess the initial safety and efficacy profile of ANV419 intravenous infusion in patients with advanced solid tumours. Phase 1 will evaluate the safety and tolerability of ANV419 alone and to determine a suitable dose for Phase 2 development. Phase 2 will evaluate the preliminary efficacy and, the safest and best dose of ANV419 when used alone or together with established cancer treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Adult Disease
Intervention  ICMJE
  • Drug: ANV419
    ANV419 administered by intravenous (IV) infusion
  • Drug: CPI or Immunostimulatory agent
    CPI or other immunostimulatory administred per treatment modalities
Study Arms  ICMJE
  • Experimental: ANV419 single agent, Q2W
    Intervention: Drug: ANV419
  • Experimental: ANV419 in combination with CPI or Immunostimulatory agent, Q2W
    Interventions:
    • Drug: ANV419
    • Drug: CPI or Immunostimulatory agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Parts A and B only: Histologically confirmed relapsed/refractory advanced solid tumor, progressing after at least one line of treatment for advanced or metastatic disease.
  • Parts C and D only: Histologically confirmed solid tumors, relapsed post or were refractory to at least one line of treatment for advanced disease. BRAF mutant melanoma must have progressed to BRAF + MEK inhibitor.
  • Parts C and D only: Radiologically measurable disease as per RECIST v1.1.
  • 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 asthenia [up to grade 2 allowed]).
  • Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential and women <12 months after menopause.
  • For women who are not postmenopausal and have not undergone surgical sterilization: agreement to remain abstinent or use two adequate highly effective non-hormonal methods of contraception, including at least one method with a failure rate of <1 % per year, during the treatment period and until 6 months after the last dose of study treatment.
  • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 6 months after the last dose of study treatment.
  • 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 <75000/mm3.
  • Liver: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN), total bilirubin > 1.5xULN (in documented Gilbert's syndrome > 3mg/dl) however, if caused by liver metastasis as judged by the Investigator and Sponsor AST and ALT >5xULN.
  • International normalized ratio (INR) >1.5xULN.
  • Serum creatinine < 1.5 mg/dL or a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula.
  • Known replicating human immunodeficiency virus (HIV) or known 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christoph Bucher, Dr 0041768243366 anv419-001clinicaltrial@anaveon.com
Contact: Andreas Katopodis 0041797308717 anv419-001clinicaltrial@anaveon.com
Listed Location Countries  ICMJE Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04855929
Other Study ID Numbers  ICMJE ANV419-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anaveon AG
Study Sponsor  ICMJE Anaveon AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christoph Bucher Anaveon AG
PRS Account Anaveon AG
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP