The Efficacy of TROP2-ADC in Advanced Extrapulmonary High-Grade Neuroendocrine Neoplasms Failure … (NCT07077564) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Efficacy of TROP2-ADC in Advanced Extrapulmonary High-Grade Neuroendocrine Neoplasms Failure of Standard Therapy
35 participantsStarted 2025-07-20
Plain-language 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-â…¡-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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent and voluntarily participate in the study.
✓. Aged 18-75 years, male or female.
✓. Histologically or cytologically confirmed diagnosis of one of the following:
✓. Progression after at least one prior line of systemic therapy.
✓. ECOG Performance Status of 0 or 1.
✓. Life expectancy ≥3 months.
✓. At least one measurable lesion per RECIST 1.1 at baseline:
✓. Lesions must not have received prior local therapy (e.g., radiotherapy). Lesions within prior radiotherapy fields are acceptable if progression is documented.
Exclusion criteria
✕. NYHA Class II+ heart failure
✕. Unstable angina
✕
What they're measuring
1
Objective Response Rate(ORR)
Timeframe: 2 months
Trial details
NCT IDNCT07077564
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University