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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04855929

Studienbeginn:
Mai 2021

Letztes Update:
12.02.2024

Wirkstoff:
ANV419, Ipilimumab

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Anaveon AG

Collaborator:
-

Studienleiter

Eduard Gasal, MD
Study Director
Anaveon AG

Kontakt

Claudia Schusterbauer, MD
Kontakt:
Phone: +41615218383
E-Mail: anv419-001clinicaltrial@anaveon.com» Kontaktdaten anzeigen

Eduard Gasal, MD
Kontakt:
Phone: +41615218383
E-Mail: anv419-001clinicaltrial@anaveon.com» Kontaktdaten anzeigen

Studienlocations
(3 von 5)

Hospital Vall d'Hebrón
Barcelona
SpainRekrutierend» Google-Maps

START Madrid, Hospital Universitario HM Sanchinarro
Madrid
SpainRekrutierend» Google-Maps

University Hospital Basel
Basel
SwitzerlandRekrutierend» Google-Maps

Cantonal Hospital St.Gallen
Saint-Gall
SwitzerlandRekrutierend» Google-Maps

Royal Marsden Hospital
London
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

The purpose of this First-in-Human, open-label, dose escalation study is to assess the

initial safety and efficacy profile of ANV419 intravenous infusion alone and in combination

with ipilimumab in patients with advanced solid tumours. It will evaluate the safety and

tolerability of ANV419 alone and in combination with ipilimumab and, the safest and best dose

of ANV419 when used alone or in combination.

Ein-/Ausschlusskriterien

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

- 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

- Part D only: Histologically confirmed relapsed/refractory advanced solid tumors

progressing after at least one line of treatment for advanced disease. Patients with

NSCLC who do not meet inclusion criteria for Part C, are eligible for Part D

- 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

Exclusion Criteria:

- 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.

- 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 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.

- 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.

Additional exclusion criteria for Part D:

- Experienced unacceptable drug-related toxicity with prior ipilimumab treatment

(defined as toxicities that required second line immunosuppression, ie, not controlled

by steroids alone)

- Received ipilimumab within 6 months prior to cycle 1 day 1.

- Known hypersensitivity to ipilimumab or any of its excipients

- Patients with active autoimmune disease or a history of autoimmune disease (other than

vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism),

- Symptomatic interstitial lung disease

- Concomitant use of therapeutic anti-coagulation (e.g.to treat pulmonary embolus or

deep vein thrombosis). Prophylactic anti-coagulation is permitted.

Studien-Rationale

Primary outcome:

1. Monotherapy: Number of Dose-Limiting Toxicities (DLTs) (Time Frame - Day 1 to Day 14)

2. Combination: Number of Dose-Limiting Toxicities (DLTs) (Time Frame - Day 1 to Day 21)

3. Monotherapy: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Day 1 up to 12 months)

4. Combination: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Day 1 up to 12 months)

5. Monotherapy: Recommended Phase 2 Dose (Time Frame - Day 1 to Day 28)

6. Combination: Recommended Phase 2 Dose (Time Frame - Day 1 to Day 28)

Secondary outcome:

1. Objective response rate (ORR) assessed by RECIST v1.1 for solid tumors (Time Frame - Day 1 up to 12 months)

2. Plasma concentration of ANV419 in blood (Time Frame - Day 1 up to 12 months)

3. Impact of ANV419 on the expression of markers of PBMC lineage in blood (Time Frame - Day 1 up to 12 months)

4. Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)

5. Disease control according to RECIST v1.1 (Time Frame - Day 1 up to 12 months)

6. Progression-free survival (PFS) according to RECIST v1.1 (Time Frame - Day 1 up to 12 months)

7. Duration of response (DOR) according to RECIST v1.1 (Time Frame - Day 1 up to 12 months)

8. Overall survival (OS) (Time Frame - Day 1 up to 12 months)

9. Quality of life assessed with European Quality of Life Five Dimensions (EQ-5D-5L) (Time Frame - Day 1 up to 12 months)

10. 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)

Studien-Arme

Experimental: ANV419 single agent
Experimental: Ipilimumab + ANV419

Geprüfte Regime

ANV419:
ANV419 administered by intravenous (IV) infusion
Ipilimumab:
Ipilimumab administered by intravenous (IV) infusion

Quelle: ClinicalTrials.gov

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