Informations générales (source: ClinicalTrials.gov)
A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)
Interventional
Phase 2
Merus N.V. (Voir sur ClinicalTrials)
janvier 2015
décembre 2026
10 octobre 2024
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single
agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor
activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1
fusion (eNRGy)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:26 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:31 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Marie Wislez, MD | Contact (sur clinicalTrials) | |||
| 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 Leon Berard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hospital Louis Pradel, FR - Lyon - France | Michael Duruisseaux, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a
limited number of patients (up to 15) in Group H;
- Performance status of ECOG 0 - 2;
- Estimated life expectancy of at least 12 weeks;
- Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade
1;
- Treatment with anti-cancer medication or investigational drugs within the following
intervals before the first dose of MCLA-128:
1. more than 14 days or more than 5 half-lives prior to study entry, whichever is
shorter.
2. more than 14 days for radiotherapy.
- Recovery from major surgery or other complication to ≤ Grade 2 or baseline ;
- Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for
at least 7 days prior to screening;
- Platelets ≥75 x 109/L without transfusion support for at least 7 days prior to
screening;
- Hemoglobin ≥8 g/dL or ≥5 mmol/L;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of
normal (ULN) and total bilirubin ≤1.5 x ULN; in cases of metastatic liver
involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed; in cases
of antecedents of Gilbert's syndrome when total bilirubin ≤3.0 x ULN or direct
bilirubin ≤1.5 x ULN will be allowed;
- Estimated glomerular filtration rate (GFR) of more than 30 mL/min
- Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 month after
completion of study therapy;
- Patients must have received prior standard therapy appropriate for their tumor type
and stage of disease, or in the opinion of the Investigator, would be unlikely to
tolerate or derive clinically meaningful benefit from appropriate standard of care
therapy or no satisfactory alternative treatment options are available;
- Locally-advanced unresectable or metastatic solid tumor malignancy with documented
NRG1 gene fusion, identified through molecular assays such as next generation
sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other
similarly-certified laboratories.
- At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a
limited number of patients (up to 15) in Group H;
- Performance status of ECOG 0 - 2;
- Estimated life expectancy of at least 12 weeks;
- Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade
1;
- Treatment with anti-cancer medication or investigational drugs within the following
intervals before the first dose of MCLA-128:
1. more than 14 days or more than 5 half-lives prior to study entry, whichever is
shorter.
2. more than 14 days for radiotherapy.
- Recovery from major surgery or other complication to ≤ Grade 2 or baseline ;
- Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for
at least 7 days prior to screening;
- Platelets ≥75 x 109/L without transfusion support for at least 7 days prior to
screening;
- Hemoglobin ≥8 g/dL or ≥5 mmol/L;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of
normal (ULN) and total bilirubin ≤1.5 x ULN; in cases of metastatic liver
involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed; in cases
of antecedents of Gilbert's syndrome when total bilirubin ≤3.0 x ULN or direct
bilirubin ≤1.5 x ULN will be allowed;
- Estimated glomerular filtration rate (GFR) of more than 30 mL/min
- Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 month after
completion of study therapy;
- Patients must have received prior standard therapy appropriate for their tumor type
and stage of disease, or in the opinion of the Investigator, would be unlikely to
tolerate or derive clinically meaningful benefit from appropriate standard of care
therapy or no satisfactory alternative treatment options are available;
- Locally-advanced unresectable or metastatic solid tumor malignancy with documented
NRG1 gene fusion, identified through molecular assays such as next generation
sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other
similarly-certified laboratories.
- Pregnant or lactating;
- Presence of an active uncontrolled infection or an unexplained fever;
- Known hypersensitivity to any of the components of MCLA-128;
- Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C;
patients treated for Hepatitis C and have undetectable viral loads are eligible
- Known symptomatic or unstable brain metastases;
- Patients with leptomeningeal metastases;
- Presence of LVEF below 50% on the screening echocardiogram; or history or presence
of any significant cardiovascular disease, including unstable angina or myocardial
infarction within 12 months prior to screening, congestive heart failure (NYHA Class
III or IV), or ventricular arrhythmia requiring medication;
- Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or
carcinoma in situ of the uterine cervix) unless the tumor was treated with curative
intent more than 2 years prior to study entry;
- Presence of any other medical or psychological condition deemed by the Investigator
to be likely to interfere with a patient ability to sign informed consent, cooperate
or participate in the study, or interfere with the interpretation of the results.