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

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT07314619
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Platinum-resistant Recurrent Ovarian Cancer (PROC)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Tirumotecan Combined with Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 2, 2026
Start date
Dec 30, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab tirumotecan combined with bevacizumab

Primary Outcome Measure

ORR [ Time Frame: Up to 24 months ]

Central Contacts