| Title |
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 |
| ClinicalTrials.gov ID |
NCT05489211 |
| Cancer Type(s) |
Solid Tumors |
| Phase |
Phase II |
| Stage |
Advanced or metastatic disease |
| Study Type |
Clinical |
| Drug |
Datopotamab deruxtecan en monothérapie et en association avec des agents anticancéreux |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
|
| Principal Investigator |
Dr. Ramy Saleh
|
| Coordinator |
Rodrigo Skowronski
514-934-1934 poste 36275
|
| Status |
Recruiting |
| Activation Date |
18-11-2022 |
| Eligibility Criteria |
- 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
|
| Exclusion Criteria |
- 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.
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Groupe d'étude en oncologie du Québec