Trodelvy (sacituzumab govitecan-hziy)

P2, N=30, Not yet recruiting, First Hospital of China Medical University

This first international real-world series of SG in mMpTNBC shows clinically relevant activity and manageable toxicity, addressing a critical evidence gap and supporting further prospective studies, particularly in PD-L1-positive disease.

While SG has shown significant clinical benefit, the objective response rate (ORR) observed with SG in pretreated mTNBC patients in the Phase I/II basket study was 33.3%, indicating a heterogeneous response profile to SG. This article explores the potential influence of autophagy, senescence, and the patient's immune system on the treatment response.

P1/2, N=76, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting

P2, N=50, Completed, MedSIR | Active, not recruiting --> Completed

P1/2, N=46, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Apr 2026 --> Sep 2025

Recent trials demonstrate encouraging outcomes with ADC such as Enfortumab Vedotin (EV), Sacituzumab Govitecan (SG), Trastuzumab Deruxtecan (T-DXd), and Disitamab Vedotin (DV) in UC, improving response rates and Progression-Free Survival (PFS). In RCC, ADC against ENPP3, CD70, and TIM-1 show durable responses in early trials, though challenges such as dose-limiting toxicities require further investigation. Overall, this review underscores ADC as a transformative approach in uro-oncology, highlighting ongoing advancements in combination strategies and biomarker-driven applications to refine therapeutic outcomes and expand treatment options for these challenging malignancies.

P3, N=614, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=54, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Sep 2026 --> Jul 2027

Regarding the conjugation type, only trastuzumab deruxtecan, labetuzumab govitecan, sacituzumab govitecan, BYON3521, and SYD1875 used homogeneous conjugation. An interesting observation was that for some ADCs, TAA expression was higher in normal tissue than in the tumor. In summary, our analysis highlights that only a limited number of ADCs incorporate payloads with favorable physicochemical properties and that several ADCs currently under development target TAAs with higher expression in normal tissues than in the corresponding tumors.

P1/2, N=792, Recruiting, Hoffmann-La Roche | N=580 --> 792 | Trial completion date: May 2028 --> Sep 2030 | Trial primary completion date: May 2028 --> Sep 2030

P=N/A, N=100, Recruiting, Peking University Cancer Hospital & Institute