A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line
This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer
| Condition(s) | Cervical Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer |
| Who can participate | Inclusion Criteria: 1. a)Patients with histologically confirmed HER2-expressing recurrent or metastatic cervical cancer who have failed at least 1 line of standard platinum-containing therapy ; b) Not suitable for surgery or radiotherapy; 2. Voluntarily agreed to participate in the study and signed an informed consent form. 3. Female, age ≥ 18 years 4. Expected survival ≥ 12 weeks 5. Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH. 6. Central laboratory confirmation of PD-L1 expression 7. Measurable disease according to RECIST 1.1 standard 8. ECOG physical condition 0 or 1 point 9. Adequate organ function, criteria should be met during the screening period 1. ANC ≥1,500/µL 2. platelet count ≥100,000/μL 3. hemoglobin ≥9.0 |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | RemeGen Co., Ltd. |
| Locations | Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Nanning, Guangxi, China; Changsha, Hunan, China; Nanchang, Jiangxi, China (+6 more sites) |
| Start date | 2024-01-11 |
| NCT ID | NCT06155396 |
| Official listing | https://clinicaltrials.gov/study/NCT06155396 |