| Titre |
A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2 |
| Protocole ID |
SGNDV-005 |
| ClinicalTrials.gov ID |
NCT06003231 |
| Type(s) de cancer |
Tumeurs solides |
| Phase |
Phase II |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
Disitamab Vedotin |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Vincent Castonguay
|
| Coordonnateur(trice) |
Maryse Gingras
418-525-4444 poste 67322
|
| Statut |
 Actif en recrutement |
| Date d'activation |
06-10-2023 |
| Critètes d'éligibilité |
-
Cohort 1: HNSCC
- Pathologically-documented squamous cell carcinoma of the head and neck with primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and larynx
- Unresectable locally recurrent or metastatic stage disease
-
Prior therapies:
- Participants must have disease progression after treatment with a platinum-based therapy
- No more than 1 line of cytotoxic chemotherapy for advanced disease
-
Cohort 2: NSCLC
- Pathologically documented NSCLC
- Unresectable locally-advanced or metastatic stage disease
-
Prior therapies
- Must have progressed during or after a platinum-based therapy or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease
- Must have received prior anti-PD(L)1 therapy, unless contraindicated
- No more than 2 prior lines of cytotoxic chemotherapy for advanced disease
-
Cohort 3: Ovarian Cancer
- Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin
- Unresectable locally-advanced or metastatic stage disease
-
Prior therapies
- Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence)
- Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease
- May have received prior anti-PD(L)1 therapy
-
Cohort 4: Endometrial Cancer
- Must have pathologically documented adenocarcinoma of the endometrium
- Must have unresectable locally-advanced or metastatic stage disease.
-
Prior therapies
- Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease
- Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease
- May have received prior anti-PD(L)1 therapy
- HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue
- Measurable disease per RECIST v1.1 criteria as assessed by the investigator
- Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
|
| Critètes d'exclusion |
- Prior treatment with an MMAE-containing agent.
- Previous treatment with HER2-directed ADCs
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
- History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Active untreated CNS or leptomeningeal metastasis
|
Groupe d'étude en oncologie du Québec