Table 3.

Ongoing clinical trials evaluating ladiratuzumab vedotin, trastuzumab duocarmazine, and disitamab vedotin

Register number (target accrual, N)	Design; arms and regimen	Study population	Primary outcome	Status
SGN-LIV1A
NCT03310957 N = 122	Phase I/II, single arm; SGN-LIV1A plus pembrolizumab	Metastatic TNBC	ORR, incidence of AEs and DLT	Accruing
NCT01969643 N = 418	Phase I dose escalation and dose expansion; different cohorts will receive SGN-LIV1A monotherapy or in combination with trastuzumab	Metastatic TNBC and HER2-positive	Incidence of AEs	Accruing
Morpheus-TNBC NCT03424005 N = 280	Phase Ib/II, open label, randomizing to several cohorts, including one of atezolizumab plus sacituzumab govitecan	Metastatic TNBC	ORR, frequency of AEs	Accruing
Trastuzumab duocarmazine
TULIP NCT03262935 N = 436	Phase III; open label, randomizing to one of two arms: trastuzumab duocarmazine vs. TPC	HER2-positive, refractory to at least two lines of CT for MBC	PFS	Completed; results pending
NCT04235101 N = 436	Phase I, single arm; trastuzumab duocarmazine plus niraparib	HER2-positive or HER2-low tumors for which no standard therapy exists	Frequency of AEs	Accruing
NCT04602117 N = 27	Phase I, single arm; trastuzumab duocarmazine plus paclitaxel	HER2-positive or HER2-low tumors for which no standard therapy exists	Frequency of AEs	Not recruiting yet
Disitamab vedotin (RC48-ADC)
NCT04400695 N = 366	Phase III; open label, randomizing to one of two arms: trastuzumab duocarmazine vs. TPC	HER2-low breast cancer; one to two prior lines of treatment in the advanced setting. Prior treatment with anthracyclines	To assess efficacy (PFS) of ADC vs. control arm	Not recruiting yet
NCT03500380 N = 228	Randomized phase II (vs. lapatinib plus capecitabine)	HER2-positive breast cancer; prior treatment with trastuzumab; one to two prior lines of treatment in the advanced setting	To assess efficacy (PFS) of ADC vs. control arm	Accruing; no results to date

ADC antibody–drug conjugate, AE adverse events, CT chemotherapy, DLT dose-limiting toxicity, HER2 human epidermal growth factor receptor 2,, MBC metastatic breast cancer, ORR objective response rate, PFS progression-free survival, SGN-LIV1A ladiratuzumab vedotin, TNBC triple-negative breast cancer, TPC treatment of physician’s choice