| Titre |
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer |
| Protocole ID |
TAK-280-1501 |
| ClinicalTrials.gov ID |
NCT05220098 |
| Type(s) de cancer |
Autre |
| Phase |
Phase I-II |
| Type étude |
Clinique |
| Médicament |
TAK-280 |
| Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
 HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
| Ville |
Sherbrooke |
| Investigateur(trice) principal(e) |
Dr Michel Pavic
|
| Coordonnateur(trice) |
Christine Lawson
819-346-1110 poste 12942
|
| Statut |
 Actif en recrutement |
| Date d'activation |
15-02-2024 |
| Critètes d'éligibilité |
- Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable.
-
Criteria for disease state in dose escalation and cohort expansion.
- Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
- Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms.
- Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1.
- Measurable disease per RECIST V1.1 by investigator except for participants with PC and only bone metastases (these participants are allowed in the study).
|
| Critètes d'exclusion |
- History of known autoimmune disease.
- Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.
- Unhealed wounds from surgery or injury.
- Ongoing or active infection of Grade >=2.
- Oxygen saturation less than (<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment.
- Inflammatory process that has not resolved for >= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration.
- Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug. Inactivated annual influenza vaccination is allowed.
- Known hypersensitivity to TAK-280 or any excipient.
|
Groupe d'étude en oncologie du Québec