Clinical Research Directory
Browse clinical research sites, groups, and studies.
Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer
Sponsor: Peking University Cancer Hospital & Institute
Summary
This study is a prospective, multicenter, single-arm, open-label phase II clinical trial. It is planned to enroll 53 subjects with HER2-expressing (IHC 1+, 2+, or 3+) partially platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (defined as disease recurrence occurring ≥6 months and \<12 months after the completion of the last platinum-containing therapy). The study adopts a two-stage sequential treatment strategy: Stage 1: All enrolled subjects will receive Trastuzumab Rezetecan (4.8 mg/kg IV, Q3W) combined with Bevacizumab (7.5 mg/kg IV, Q3W). Trastuzumab Rezetecan will be administered for a maximum of 1 year, or until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria are met, whichever occurs first; Bevacizumab will be continued until disease progression, unacceptable toxicity, or other protocol-defined reasons. Stage 2: Upon confirmed disease progression in Stage 1, subjects will enter Stage 2 to receive platinum-based chemotherapy (e.g., Carboplatin + Paclitaxel, Carboplatin + Liposomal Doxorubicin, or Carboplatin + Gemcitabine ± Bevacizumab; Cisplatin or Nedaplatin may replace Carboplatin in cases of intolerance, including but not limited to these regimens, determined by the investigator) until subsequent disease progression or unacceptable toxicity. The primary objective is to evaluate progression-free survival 1 (PFS1) of SHR-A1811 combined with bevacizumab based on RECIST v1.1. Secondary objectives include objective response rate (ORR), disease control rate (DCR), progression-free survival 2 (PFS2), overall survival (OS), and safety and tolerability.
Official title: Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II, Multicenter, Single-Arm Study
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2026-10-22
Completion Date
2029-09-30
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
Trastuzumab Rezetecan (SHR-A1811)
Humanized anti-HER2 IgG1 monoclonal antibody conjugated with a topoisomerase I inhibitor payload (SHR169265). Administered IV at 4.8 mg/kg on Day 1 of each 21-day cycle.
Bevacizumab
Recombinant humanized anti-VEGF monoclonal antibody. Administered IV at 7.5 mg/kg on Day 1 of each 21-day cycle (dosing interval \>30 min after SHR-A1811).
Platinum-based chemotherapy
Platinum-based chemotherapy rechallenge administered in Stage 2, selected by the investigator based on patient clinical condition (including but not limited to: Carboplatin + Paclitaxel ± Bevacizumab, Carboplatin + Pegylated Liposomal Doxorubicin ± Bevacizumab, or Carboplatin + Gemcitabine ± Bevacizumab; Cisplatin or Nedaplatin may be substituted if carboplatin is not tolerated).
Locations (1)
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China