Trodelvy (sacituzumab govitecan-hziy)

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

Clinical trials exploring Trop2 directed ADCs such as Sacituzumab-Govitecan are warranted in this cancer type, including the prognostically poor HPV-independent (p16 negative) tumors, mainly adenocarcinomas. Regardless of the histologic tumor type and p16-expression status, cervical carcinomas show high Trop2 expression, which may therefore represent a promising therapeutic target in these tumors.

Previous studies showed ADC and immunotherapy combinations are effective in advanced NSCLC, suggesting potential perioperative benefit. This study aims to improve pCR rate, reduce toxicity, enhance surgical eligibility, and personalize adjuvant treatment to improve long-term outcomes.Clinical Trial Registration: EudraCT: 2024-517561-16.

There are differences in pharmacological effects, efficacy, and incidence of adverse events among sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan. For patients with EGFR-mutated progression after targeted therapy or driver gene negative advanced non-small cell lung cancer, the individualized optimization of TROP2 ADCs treatment can obtain the greatest benefit.

HGSOC patients with chemotherapy and sacituzumab govitecan-resistant disease may experience durable responses with the sequential use of trastuzumab deruxtecan. ADCs with a similar cytotoxic payload but targeting a different antigen may represent effective treatment options in patients with HGSOC.

P2, N=53, Active, not recruiting, Gilead Sciences | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026

The rapid tumor targeting and favorable pharmacokinetics of 64Cu-NOTA-Trodelvy-F(ab')2 support its utility as a same-day ImmunoPET imaging agent. This practical and sensitive platform is highly valuable for patient stratification and therapeutic monitoring in Trop2-targeted cancer treatment.

P3, N=320, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting