Informations générales (source: ClinicalTrials.gov)
LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors
Interventional
Phase 1/Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
août 2024
mars 2029
22 juillet 2025
Substudy 01A is part of a platform study. The purpose of this study is to assess the
efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or
refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma
(DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants
with Ewing sarcoma.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Study Coordinator | 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 | |||||
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102) - 13005 - Marseille - Provence-Alpes-Cote-d Azur - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104) - 44093 - Nantes - Pays-de-la-Loire - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100) - 69373 - Lyon - Rhone-Alpes - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux. Hopital Pellegrin ( Site 1105) - 33076 - Bordeaux - Aquitaine - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or
DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification
of neoplasms of the lymphoid tissues.
- For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or
Ewing sarcoma.
Exclusion Criteria:
- History of solid organ transplant.
- Clinically significant (ie, active) cardiovascular disease.
- Known history of liver cirrhosis.
- Ongoing Grade >1 peripheral neuropathy.
- Demyelinating form of Charcot-Marie-Tooth disease.
- Diagnosed with Down syndrome.
- Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD
treatment or prophylaxis.
- History of human immunodeficiency virus (HIV) infection.
- Contraindication or hypersensitivity to any of the study intervention components.
- Received prior radiotherapy within 4 weeks of start of study intervention.
Participants must have recovered from all radiation-related toxicities.
- Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone
equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks
before Cycle 1 Day 1 (C1D1).
- Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong
CYP3A4 inducer within 14 days before the start of study intervention or expected
requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study
intervention period and for 30 days after the last dose of study intervention
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before the first dose of study intervention (except for prophylactic
intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration.
- Known additional malignancy that is progressing or has required active treatment
within the past 1 year.
- Active infection requiring systemic therapy.
- Known history of Hepatitis B or known active Hepatitis C virus infection.
- Participants who have not adequately recovered from major surgery or have ongoing
surgical complications.
Inclusion Criteria:
- For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or
DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification
of neoplasms of the lymphoid tissues.
- For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or
Ewing sarcoma.
Exclusion Criteria:
- History of solid organ transplant.
- Clinically significant (ie, active) cardiovascular disease.
- Known history of liver cirrhosis.
- Ongoing Grade >1 peripheral neuropathy.
- Demyelinating form of Charcot-Marie-Tooth disease.
- Diagnosed with Down syndrome.
- Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD
treatment or prophylaxis.
- History of human immunodeficiency virus (HIV) infection.
- Contraindication or hypersensitivity to any of the study intervention components.
- Received prior radiotherapy within 4 weeks of start of study intervention.
Participants must have recovered from all radiation-related toxicities.
- Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone
equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks
before Cycle 1 Day 1 (C1D1).
- Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong
CYP3A4 inducer within 14 days before the start of study intervention or expected
requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study
intervention period and for 30 days after the last dose of study intervention
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before the first dose of study intervention (except for prophylactic
intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration.
- Known additional malignancy that is progressing or has required active treatment
within the past 1 year.
- Active infection requiring systemic therapy.
- Known history of Hepatitis B or known active Hepatitis C virus infection.
- Participants who have not adequately recovered from major surgery or have ongoing
surgical complications.