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

NCT07077564 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-22

No results posted yet for this study

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

DRUG

Sac-TMT

Sacituzumab govitecan 5 mg/kg every 2 weeks on Day 1 of each cycle（IV）

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2027-07-20
Completion
2028-07-20

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077564 on ClinicalTrials.gov