A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients with Advanced Cancer.

NCT04855929 | Completed Phase 1

• 1 other identifier: ANV419-001
• Study Type: interventional
• Target: 55
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Advanced Solid Tumor; Adult Disease; Lung Cancer

Keywords

IL-2; ANV419; Cancer; Relapsed; Refractory; Ipilimumab

Outcome Measures

Primary Outcomes (6)

• Monotherapy: Number of Dose-Limiting Toxicities (DLTs)

  Day 1 to Day 14

• Combination: Number of Dose-Limiting Toxicities (DLTs)

  Day 1 to Day 21

• Monotherapy: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to 12 months

• Combination: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to 12 months

• Monotherapy: Recommended Phase 2 Dose

  Day 1 to Day 28

• Combination: Recommended Phase 2 Dose

  Day 1 to Day 28

Secondary Outcomes (10)

• Objective response rate (ORR) assessed by RECIST v1.1 for solid tumors

  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

  Day 1 up to 12 months

Study Arms (2)

ANV419 single agent

EXPERIMENTAL

Drug: ANV419

Ipilimumab + ANV419

EXPERIMENTAL

Drug: ANV419; Drug: Ipilimumab

Interventions

ANV419 DRUG

ANV419 administered by intravenous (IV) infusion

ANV419 single agent; Ipilimumab + ANV419

Ipilimumab DRUG

Ipilimumab administered by intravenous (IV) infusion

Ipilimumab + ANV419

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Part C only: Previously treated advanced NSCLC without a driver mutation who have progressed after first line standard chemo-immunotherapy: Patients must have measurable disease using RECIST v1.1, A maximum of 1 line of therapy is permitted, Patients with high expression of PD-L1 which were treated with first line checkpoint inhibitor monotherapy may have received a maximum of 2 lines of therapy
• 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

You may not qualify if:

• Carcinomatous meningitis and/or 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.
• Significant cardiovascular/cerebrovascular disease, including myocardial infarction or transient ischemic attack (TIA) within 6 months prior to Day 1 of study drug administration.
• Active infections, or uncontrolled infection 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 \<100'000/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.
• 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.

Sponsors & Collaborators

• Anaveon AG: lead

Study Sites (5)

Hospital Vall d'Hebrón

Barcelona, Spain

Location

START Madrid, Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

Cantonal Hospital St.Gallen

Sankt Gallen, Switzerland

Location

Royal Marsden Hospital

London, United Kingdom

Location

Related Publications (1)

• Joerger M, Calvo E, Laubli H, Lopez J, Alonso G, Corral de la Fuente E, Hess D, Konig D, Sanchez Perez V, Bucher C, Jethwa S, Garralda E. Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors. J Immunother Cancer. 2023 Nov 21;11(11):e007784. doi: 10.1136/jitc-2023-007784.

  PMID: 38243906 DERIVED

MeSH Terms

Conditions

Disease; Lung Neoplasms; Neoplasms; Recurrence

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Disease Attributes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Eduard Gasal, MD

  Anaveon AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 22, 2021
• Study Start: May 25, 2021
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); ES (2); CH (2)