NCT07077564

The Efficacy of TROP2-ADC in Advanced Extrapulmonary High-Grade Neuroendocrine Neoplasms Failure of Standard Therapy

A Single-Center, Single-Arm, Phase II Clinical Trial of TROP2-ADC in Patients With Advanced Extrapulmonary High-Grade Neuroendocrine Tumors Refractory to Standard Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The response rate to second-line or later therapies for extrapulmonary high-grade neuroendocrine neoplasms (NENs) remains low, with no established standard treatment regimen. Patients exhibit short survival periods, with median overall survival ranging from 5.1 to 18 months, representing a significant unmet clinical need. Sacituzumab govitecan has been evaluated in multiple clinical trials including OptiTROP-Breast01, KL264-01, OptiTROP-Lung01, OptiTROP-Lung03, and SKB264-Ⅱ-06. Current results consistently indicate promising efficacy of Sacituzumab govitecan in lung cancer, breast cancer, and cervical cancer. Notably, data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting revealed that TROP2 is highly expressed in neuroendocrine tumors, and its expression is significantly associated with poor prognosis. This suggests TROP2-directed antibody-drug conjugates (ADCs) may demonstrate promising therapeutic potential in NENs. Research Objective:To evaluate the efficacy of Sacituzumab govitecan in patients with advanced extrapulmonary neuroendocrine neoplasms who have progressed on standard therapies.

Conditions

• Neuroendocrine Neoplasms (Tumours)

Interventions

Type	Name	Description
DRUG	Sac-TMT	Sacituzumab govitecan 5 mg/kg every 2 weeks on Day 1 of each cycle（IV）

Timeline

• Start date: 2025-07-20
• Primary completion: 2027-07-20
• Completion: 2028-07-20
• First posted: 2025-07-22
• Last updated: 2025-07-22