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RC48 Plus Platinum With or Without Bevacizumab in HER2+ Recurrent Ovarian Cancer
NCT06420973Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2024
- Primary completion
- May 2027
- Countries
- 1
- Sponsor
- Peking University Cancer Hospital & Institute
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)
- Drugs
- disitamab vedotin
- Conditions
- ovarian carcinomafallopian tube carcinoma (PFTC)primary peritoneal carcinoma (PPC)
01
Overview
Phase 2, open-label, single-arm trial of disitamab vedotin in ovarian carcinoma, fallopian tube carcinoma (PFTC) and primary peritoneal carcinoma (PPC), sponsored by Peking University Cancer Hospital & Institute. Primary endpoint: Progression-Free Survival at 2 years. Started May 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
RC48+carboplatin±bevacizumab
RC48 + Carboplatin +/- Bevacizumab for 6 cycles, followed by RC48 +/- Bevacizumab maintenance therapy.
03
Who it enrols
Female patients aged 18-75 with HER2-expressing (IHC 1+, 2+, or 3+) platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have received 1-4 prior lines of therapy and no prior HER2-targeted therapy.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Disease Control Rate
Overall Survival
Adverse Events
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