Table 1.

Summary of available data regarding TROPION-PanTumor01 and BEGONIA.

NCT Number/Trial name	Trial Design/Patient Population	Characteristics	Number of pts	Intervention	Primary endpoint	Clinical Trial Data	Safety
NCT03401385, TROPION-PanTumor01	FIH trial with Datopotamab deruxtecan in refractory metastatic TNBC (N = 44)	A Phase 1, Two-Part, Multicenter, Open-Label, Multiple-Dose, First-in-Human Study of Dato-DXd in Patients With Advanced/Metastatic Solid Tumors	770	Drug: Datopotamab Deruxtecan (Dato-DXd) Drug: Steroid Containing Mouthwash Other: Non-Steroid Containing Mouthwash	Safety and tolerability	ORR 32% (ORR-44% in Topo I inhibitors-naive patients)	G3 AEs were observed in 52% of pts. Most common TEAEs (any grade, grade ≥3) were stomatitis (73%, 11%), nausea (66%, 2%), and vomiting (39%, 5%)
NCT03742102BEGONIA trial	Phase Ib/II platform trial with Datopotamab deruxtecan + durvalumab in first-line metastatic TNBC (N = 29)	Multi-center, Open-Label, Platform Study Evaluating the Efficacy and Safety of Durvalumab in Combination With Novel Oncology Therapies for First-Line Treatment in Patients With Metastatic TNBC	210	Drug: Durvalumab Drug: Capivasertib Drug: Oleclumab	Safety and tolerability	ORR 79% Median DoR not reached Responses were seen regardless of PD-L1 expression	G3/4 AEs were observed in 36% of pts. Most common TEAEs (any grade, grade ≥3) were gastrointestinal (nausea in 26 patients [55%] and stomatitis in 24 patients [51%])