Informations générales (source: ClinicalTrials.gov)
A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Interventional
Phase 2
Inhibrx Biosciences, Inc (Voir sur ClinicalTrials)
septembre 2021
décembre 2026
14 septembre 2025
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients.
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 | Yasmine Bouredjoul | 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 | |||||
| AP-HM - Hôpital de la Timone - 13005 - Marseille - France | Annick Pelletier | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - 69373 - Lyon - France | Julien Timmins | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Loic Lebellec, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonie - 33076 - Bordeaux - Cedex - France | Justine Retailleau | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously
irradiated (or other locally treated) area will be considered measurable, provided
there has been clear imaging-based progression of the lesions since the time of
treatment.
3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to
screening for this study.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per
protocol.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.
1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously
irradiated (or other locally treated) area will be considered measurable, provided
there has been clear imaging-based progression of the lesions since the time of
treatment.
3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to
screening for this study.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per
protocol.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.
1. Any prior exposure to DR5 agonists.
2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal
myxoid, myxoid, and dedifferentiated chondrosarcoma.
4. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent
malignancy whose natural history or treatment does not have the potential to
interfere with the safety or efficacy assessments.
5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable
as long as adequate hepatic function as defined in the inclusion/exclusion criteria
is confirmed.
6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
7. Other exclusion criteria per protocol.