Informations générales (source: ClinicalTrials.gov)
A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer
Interventional
Phase 1
Enliven Therapeutics (Voir sur ClinicalTrials)
mars 2023
juillet 2026
13 août 2025
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an
abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and
tolerable at different doses. A second main question is to evaluate the concentration of
ELVN-002 in the blood at different doses and to see how this correlates with safety and
see how the concentration of drug changes over time. The third main question is to see if
ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly
non-small cell lung cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 17/05/2024 14:02:02 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Francois Baclesse - 14076 - Caen - Calvados - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| EDOG - Institut Bergonie - PPDS - 33000 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone Centre d'essais en cancérologie de Marseille (CEPCM-CLIPP) - 13005 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pontchaillou - 35033 - Rennes - Brittany - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
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
Exclusion Criteria All Phases:
- 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)
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
Exclusion Criteria All Phases:
- 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)