Relapsed/refractory advanced solid tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: ANV419
Product Code: ANV419
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ANV419
Current Sponsor code: ANV419
Other descriptive name: Fusion protein of
Sponsors
Anaveon AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet the following criteria to be enrolled in this study: 1.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. 2.Male or female aged > or = 18 years. 3.Advanced solid tumors with evidence of progressive disease as per RECIST no longer than 3 months before ICF signature, without any subsequent curative intent treatment. 4.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. 5.Parts C and D only: Histologically confirmed advanced metastatic melanoma or renal cell carcinoma, relapsed or refractory after at least one line of treatment for advanced disease. BRAF mutant melanoma must have progressed to BRAF + MEK inhibitor. 6.Parts C and D only: Radiologically measurable disease as per RECIST v1.1. 7.No additional established line of on-label treatment is available or there is a contraindication for the indicated labelled therapies. 8.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 9.Adequate pulmonary, cardiovascular, hematological, liver and renal function, per Investigator judgment. 10.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]). 11.Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential and women =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1.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. 2.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 are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable. 3.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, 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. 4.Significant cardiovascular/cerebrovascular disease, including myocardial infarction (MI) or Transient Ischemic Attack TIA within 6 months prior to Day 1 of study drug administration. 5.Active or uncontrolled infections requiring systemic antibiotics within one week (7 days) preceding Day 1 of treatment. 6.Hemoglobin (Hb) 2.5 ULN, total bilirubin > 1.5 ULN (in documented Gilbert’s syndrome > 3mg/dl) however, if caused by liver metastasis as judged by the Investigator and Sponsor AST and ALT >5x ULN. 10.International normalized ratio (INR) >1.5x ULN. 11.Serum creatinine < 1.5 mg/dL and a measured creatinine clearance = 50 mL/min using the Cockcroft-Gault formula (Appendix 11.4). 12.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. 13.Positivity for coronavirus disease 2019 (COVID-19) by naso-pharyngeal swab test. Known serologic conversion is not an exclusion criterion. 14.Evidence of hepatic cirrhosis with Child-Pugh score C. 15.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug. 16.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. 17.Severe altered mental status. 18.Pregnant or breastfeeding women. 19.Known hypersensitivity to any of the components of ANV419 or its formulation. 20.Concurrent therapy with any other investigational drug within one month prior to Day 1 of study drug administration. 21.Active untreated Immune-related endocrinopathies. 22.Chronic treatment with systemic immunosuppressive medications above 10mg/d Prednisolone equivalent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A and Part B : To evaluate the safety and tolerability of ANV419, and to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of ANV419-Part C: to evaluate the preliminary efficacy of ANV419 administered as a single agent in selected cohorts in relapsed/refractory advance solid tumor. -Part D (combination with checkpoint inhibitor [CPI] or other immunostimulatory treatment modalities) will have two sequential phases: -Cohort 1 run-in portion: intra-patient dose escalation to confirm the optimal dose of ANV419 when given in combination with CPI or other immunostimulatory treatment modalities in approved indications and dosage per label. The run in phase is expected to start at 50% of the RP2D or 50% of the highest dose proven safe showing a biological activity in Part B (0/3 DLT or 1/6 DLT). -Cohort 2: To evaluate the preliminary efficacy of ANV419 in combination with CPI or other immunostimulatory treatment modalities.;Secondary Objective: The secondary objectives of this study are as follows: Part A and Part B: To characterize the pharmacokinetics (PK), pharmacodynamics, immunogenicity, and tumor response according to modified RECIST v1.1 criteria for immune-based therapeutics (iRECIST) of ANV419 administered by IV infusion as a single agent Part C: To further evaluate the safety, tolerability, PK, pharmacodynamics, and tumor response according to modified RECIST v1.1 criteria for immune-based therapeutics (iRECIST) of ANV419 administered by IV infusion as a single agent Part D: To further evaluate the safety, tolerability, PK, pharmacodynamic, and tumor response according to modified RECIST v1.1 criteria for immune-based therapeutics (iRECIST) of ANV419 administered by IV infusion in combination with CPI or other immunostimulatory treatment modalities.;Primary end point(s): Primary Endpoints: Phase 1: Number of patients experiencing dose-limiting toxicities (DLT) during the DLT assessment period [Day 1 to Day 14] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: Phase 1 Only: Objective response rate (CR + PR) assessed by RECIST v1.1 and iRECIST. Phase 2 Only: Incidence and severity of AEs and SAEs, changes from baseline in laboratory, vital signs, ECG, and physical examination parameters. Objective response rate (CR + PR) assessed by iRECIST;Timepoint(s) of evaluation of this end point: Phase 1 endpoints will be evaluated at the end of Phase 1 (Parts A & B dose escalation to find Recommended Phase 2 Dose). Phase 2 endpoint will be evaluated at the end of Phase 2 (Parts C & D). | — |
Countries
Spain
Contacts
Public ContactChristopher Bucher
Anaveon AG
Outcome results
None listed