| TITRE |
(EN) A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours |
| PROTOCOLE ID |
TROPION-PanTumor03 |
| CLINICAL TRIAL.gov ID |
NCT05489211 |
| TYPE(S) DE CANCER |
Tumeurs solides |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Ramy Saleh
|
| COORDONATEUR(RICE) |
Rodrigo Skowronski
rodrigo.skowronski@muhc.mcgill.ca
514-934-1934 poste 36275
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Male and female, ≥ 18 years
- Histologically or cytologically documented advanced or metastatic malignancy.
- At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline Substudy 3 (mCRPC) allows enrolment of participants with non measurable (by RECIST 1.1) bone metastatic disease.
- Adequate bone marrow reserve and organ function within 7 days before randomization/treatment
- Minimum life expectancy of 12 weeks
|
| CRITÈRES D'EXCLUSION |
(EN)
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline
- Spinal cord compression or brain metastases unless treated
- Leptomeningeal carcinomatosis
- Clinically significant corneal disease
- Active hepatitis or uncontrolled hepatitis B or C virus infection
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals eg, prodromal symptoms
- Significant cardiac diseases
- History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
- Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
- Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment
- Prior treatment with TROP2-directed Anti-drug antibody ADC Antibody-drug conjugate (ADCs), other ADCs with deruxtecan payload
- Severe hypersensitivity to Dato-DXd monoclonal antibodies polysorbate 80 or other monoclonal antibodies.
- Pregnant, breastfeeding, planning to become pregnant.
|
