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

Trial ID #	NCT05489211
Phase	II
Drug Class	Antibody Drug Conjugates: TROP2
Drug Name	Datopotamab deruxtecan
Alternate Drug Names	Dato-DXd, Anti-TROP2/DXd antibody-drug conjugate DS-1062a
Drugs in Trial	Bevacizumab, Carboplatin, Datopotamab deruxtecan, Saruparib
Eligible Participant	Platinum resistant or refractory ovarian cancer
Patients Enrolled	26, median 2 prior therapies (1-2)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, evaluated per RECIST
Efficacy	ORR: 34.6% (9PR) DCR (4 months): 80.8% DoR: 5.6 months
Clinically Significant Adverse Events	Serious AE: overall (28.6%) Grade 3-4 AE: overall (54.3%)
Conclusion	Datopotamab deruxtecan (Dato-DXd) monotherapy demonstrates encouraging efficacy and a manageable safety profile in patients with platinum resistant or refractory ovarian cancer
Reference	Oaknin A et al. Datopotamab deruxtecan (Dato-DXd) in patients with endometrial (EC) or ovarian cancer (OC): Results from the phase II TROPION-PanTumor03 study. Ann Oncol (2024) 35 (2) abstract 714MO https://www.clearityfoundation.org/wp-content/uploads/2024/11/Dato-Dxd-abstract-ESMO-2024.pdf