| Titre |
A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2 Overexpressing Gastric Cancer |
| Protocole ID |
DESTINY-Gastric03 |
| ClinicalTrials.gov ID |
NCT04379596 |
| Type(s) de cancer |
Estomac |
| Phase |
Phase I-II |
| Type étude |
Clinique |
| Médicament |
Trastuzumab Deruxtecan |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Maxime Chénard-Poirier
|
| Coordonnateur(trice) |
Maryse Gingras
418-691-5781
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Male and female participants must be at least 18 years of age
-
Disease Characteristics:
Locally advanced, unresectable, or metastatic disease Pathologically documented adenocarcinoma of the stomach or GEJ with HER2 overexpression (IHC 3+ or ICH 2+/ISH+)
-
For Part 1, progression on or after at least one prior trastuzumab containing Regimen.
For Part 2, previously untreated for unresectable or metastatic adenocarcinoma of the stomach or GEJ with HER2 overexpression.
- Has measurable target disease assessed by the Investigator based on RECIST version 1.1
- Has protocol defined adequate organ function including cardiac, renal and hepatic function
- If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.
|
| Critètes d'exclusion |
- History of active primary immunodeficiency, known HIV, active HBV or HCV infection.
- Uncontrolled intercurrent illness.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant severe illnesses.
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- Has spinal cord compression or clinically active central nervous system metastases.
|
Groupe d'étude en oncologie du Québec