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ELVN-002-001 - A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer

Studio Clinico

Patologia: Neoplasie della mammella, Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I A, I B

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

Phase 1a Monotherapy Dose Escalation and Exploration:

- Pathologically documented advanced stage solid tumor
- Progressed following all standard treatment or not appropriate for standard treatment
- HER2 mutation, HER2 amplification or HER2 positive based on local testing

Phase 1b Monotherapy

- Pathologically documented unresectable and/or metastatic non-squamous NSCLC
- HER2 mutation identified by tissue (fresh or archival) or ctDNA. Local testing for up to 20 patients the remainder centrally confirmed.
- Measurable disease
- No known epidermal growth factor receptor (EGFR), ROS1, anaplastic lymphoma kinase (ALK), or BRAF V600E mutation
- Progressed after receiving at least 1 prior systemic therapy including a platinum-based chemotherapy with or without immunotherapy, or not appropriate for standard treatment.
- No prior HER2 tyrosine kinase inhibitor. Prior HER2 directed antibodies or anti-body drug conjugates are allowed
- No limit on prior number of therapies

Phase 1a Combination with T-DXd

- Pathologically documented advanced stage NSCLC
- Progressed after receiving at least 1 prior systemic therapy.
- HER2 mutation based on local/historical testing of tissue or circulating tumor DNA
- No known EGFR, ROS1, ALK, or BRAF V600E mutation
- No prior T-DXd
- No clinically severe pulmonary compromise
- No limit on prior number of therapies

Phase 1a Combination Breast Cancer

- Documented HER2 positive (Immunohistochemical [IHC] 3+ or IHC2+/in situ hybridization (ISH+) breast cancer
- Must have previously received trastuzumab, a taxane, and T-DXd (if available and appropriate) in the metastatic setting.
- No limit on prior number of therapies
- No prior T-DM1

All Phases

- Eastern Cooperative Oncology Group performance status of 0-1
- Left ventricular ejection fraction ≥ 50%
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 8.5 g/dL
- Absolute neutrophil count ≥1.0 x 109/L
- Total bilirubin < 1.5 times upper limit of normal range (ULN), except for patients with Gilbert's syndrome
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 times ULN. In the setting of liver metastases < 5 times ULN.
- Creatinine clearance ≥ 60 mL/minute.

Criteri di esclusione: 

- Severe cardiac arrhythmias, requiring treatment, symptomatic congestive heart failure, myocardial infarction within 28 days prior to first dose, or unstable angina.
- Another active malignancy within 2 years except basal cell skin cancer and carcinoma in situ treated curatively
- Active or chronic liver disease
- Active infection requiring systemic therapy within 14 days before the first dose
- Brain lesion requiring immediate local therapy
- Leptomeningeal disease
- Uncontrolled seizures
- Corrected QT interval (QTc) of >470 milliseconds (ms) females or >450 ms for males by Fridericia (QTcF).

Trattamento sperimentale: 

ELVN-002

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
UO Oncologia Medica ed Ematologia

Riferimento: Prof. Armando Santoro
Email: armando.santoro@cancercenter.humanitas.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Prof.ssa Marina Cazzaniga
Email: centrofase1@irccs-sangerardo.it

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
SOC Oncologia medica e dei Tumori immunocorrelati

Riferimento: Dr.ssa Alessandra Bearz
Email: abearz@cro.it

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

Riferimento: Dr.ssa Vanesa Gregorc
Email: ufficio.trials@ircc.it

 

Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN

Riferimento: Prof.ssa Rossana Berardi
Email: Rossana.Berardi@ospedaliriuniti.marche.it

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Riferimento: Dr. Gennaro Daniele
Email: gennaro.daniele@policlinicogemelli.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT05650879

Data di inserimento: 18.03.2024

Promotore

Enliven Therapeutics

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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