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

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.

Sponsors

Lead Sponsor: Anaveon AG

Source Anaveon AG
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.

Overall Status Not yet recruiting
Start Date 2021-04-01
Completion Date 2023-07-01
Primary Completion Date 2023-07-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Phase I: Number of Dose-Limiting Toxicities (DLTs) Day 1 to Day 14
Phase I: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to 12 months
Phase I: Recommended Phase 2 Dose Day 1 to Day 28
Phase II: Objective Response Rate (ORR) assessed by RECIST v1.1 Day 1 up to 12 months
Secondary Outcome
Measure Time Frame
Phase I: Objective response rate (ORR) assessed by RECIST v1.1 and iRECIST Day 1 up to 12 months
Phase II: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events Day 1 up to 12 months
Phase II: Objective Response Rate (ORR) assessed by iRECIST Day 1 up to 12 months
Plasma 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
Disease control according to RECIST v1.1 and iRECIST Day 1 up to 12 months
Progression-free survival (PFS) according to RECIST v1.1 and iRECIST Day 1 up to 12 months
Duration of response (DOR) according to RECIST v1.1 and iRECIST Day 1 up to 12 months
Overall survival (OS) Day 1 up to 12 months
Quality of life assessed with European Quality of Life Five Dimensions (EQ-5D-5L) 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) Day 1 up to 12 months
Enrollment 75
Condition
Intervention

Intervention Type: Drug

Intervention Name: ANV419

Description: ANV419 administered by intravenous (IV) infusion

Intervention Type: Drug

Intervention Name: CPI or Immunostimulatory agent

Description: CPI or other immunostimulatory administred per treatment modalities

Arm Group Label: ANV419 in combination with CPI or Immunostimulatory agent, Q2W

Eligibility

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. - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Christoph Bucher Study Director Anaveon AG
Overall Contact

Last Name: Christoph Bucher, Dr

Phone: 0041768243366

Email: [email protected]

Location
Facility:
Hospital Vall Hebrón | Barcelona, Spain
START Madrid, Hospital Universitario HM Sanchinarro | Madrid, Spain
University Hospital Basel | Basel, Switzerland
Royal Marsden Hospital | London, United Kingdom
Location Countries

Spain

Switzerland

United Kingdom

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: ANV419 single agent, Q2W

Type: Experimental

Label: ANV419 in combination with CPI or Immunostimulatory agent, Q2W

Type: Experimental

Acronym ANV419-001
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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