Table 4.

Ongoing clinical trials of antibody-drug conjugates in patients with metastatic urothelial cancer

Enfortumab vedotin (anti-nectin-4 antibody conjugated to MMAE)
	EV-301 (NCT03474107), phase III	Enfortumab vedotin vs. chemotherapy (docetaxel, paclitaxel, or vinflunine)	Prior platinum-treated and ICI-treated mUC
	EV103 (NCT03288545), phase Ib-II	Enfortumab vedotin ± pembrolizumab ± chemotherapy (cisplatin, carboplatin, or gemcitabine)	Treatment-naïve cisplatin eligible/ineligible or platinum in eligible mUC
			Platinum-treated mUC
			Cisplatin-ineligible MIBC scheduled for radical cystectomy
	EV-302 (NCT04223856), phase III	Enfortumab vedotin + pembrolizumab vs. gemcitabine + cisplatin or carboplatin vs. enfortumab vedotin + pembrolizumab + cisplatin or carboplatin	Treatment-naïve cisplatin or carboplatin eligible mUC
Sacituzumab govitecan (anti-Trop-2 antibody conjugated to SN-38)
	TROPHY-U-01 (NCT03547973), phase II	Sacituzumab govitecan (cohort 1, 2)	Prior platinum-treated and ICI-treated (cohort 1) or treatment-naïve platinum-ineligible mUC (cohort 2)
		Sacituzumab govitecan + pembrolizumab (cohort 3)	Prior platinum-treated (cohort 3)
RC48-ADC (anti-HER2 antibody hertuzumab conjugated to MMAE)
	NCT04507166, phase II	RC48-ADC	Failure of at least 1 systemic chemotherapy, HER-2 IHC2+ or 3+
Trastuzumab deruxtecan (anti-HER2 antibody trastuzumab conjugated to deruxtecan)
	NCT03523572, phase Ib	Trastuzumab deruxtecan + nivolumab	Failure of platinum-based chemotherapy, HER2 IHC2+ or 3+

MMAE, monomethyl auristatin-E; ICI, immune checkpoint inhibitor; mUC, metastatic urothelial cancer; MIBC, muscle-invasive bladder cancer; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemical staining.