NCT07314619

Prospective, Multicenter, Single-Arm, Phase Ⅱ Clinical Study on the Efficacy and Safety of Sacituzumab Tirumotecan Combined With Bevacizumab in Platinum-Resistant Recurrent Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

As one of the gynecological malignancies with the highest incidence and mortality rates worldwide, ovarian cancer treatment faces the significant challenge of platinum-resistant recurrence. Patients with platinum-resistant recurrent ovarian cancer (PROC) have an extremely poor prognosis, and the survival benefits of traditional chemotherapy and bevacizumab combination therapy are limited (median progression-free survival \[mPFS\] is approximately 2-5 months, and 5-year survival rate is 30%-40%). In recent years, the antibody-drug conjugate (ADC) Sacituzumab tirumotecan has shown breakthrough potential. A phase Ⅱ study presented at the 2024 European Society for Medical Oncology (ESMO) Congress demonstrated that for patients with advanced platinum-resistant ovarian cancer (87.5% of whom had platinum resistance) treated with this drug as monotherapy, the objective response rate (ORR) reached 40%, median progression-free survival (mPFS) was 6.0 months, and disease control rate (DCR) was 75%. Furthermore, the ORR increased to 61.5% in patients with high Trop2 expression, and the safety profile was manageable.Based on the preclinical model evidence suggesting that anti-angiogenic drugs can enhance the intratumoral penetration of ADCs, the current study further explores the synergistic effect of Sacituzumab tirumotecan combined with bevacizumab. It aims to improve therapeutic efficacy by optimizing tumor microcirculation and analyze the molecular mechanisms using technologies such as organoids and single-cell sequencing, thereby providing a new strategy to overcome the bottleneck of platinum resistance.

Conditions

• Platinum-resistant Recurrent Ovarian Cancer (PROC)

Interventions

Type	Name	Description
DRUG	Sacituzumab Tirumotecan Combined with Bevacizumab	Sacituzumab Tirumotecan is administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, and is given once on Day 1 of each cycle. Bevacizumab is administered at a dose of 7.5\~15 mg/kg via intravenous infusion, once every 3 weeks. Treatment is continued until disease progression or the occurrence of intolerable toxicity.

Timeline

• Start date: 2025-12-30
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China