A Single-Arm, Open- Label, Multicenter Phase II Study 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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

• Voluntarily agreed to participate in the study and signed an informed consent form.

• Female, age ≥ 18 years

• Expected survival ≥ 12 weeks

• Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH.

• Central laboratory confirmation of PD-L1 expression

• Measurable disease according to RECIST 1.1 standard

• ECOG physical condition 0 or 1 point

• Adequate organ function, criteria should be met during the screening period

∙ ANC ≥1,500/µL

‣ platelet count ≥100,000/μL

‣ hemoglobin ≥9.0 g/dL

‣ total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin \>1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease

‣ CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine).

‣ ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases

‣ LVEF ≥\>50%

⁃ Female subjects should be surgically sterilised, post-menopausal or agree to use at least one medically approved contraceptive method during and for 6 months after the end of the study treatment period, must have had a negative blood pregnancy test within 7 days prior to study entry, and must be non-lactating.

⁃ Willingness and ability to comply with trial and follow-up procedure arrangements.

Locations
Other Locations
China
Beijing Obstetrics and Gynecology Hospital ,Capital Medical University
NOT_YET_RECRUITING
Beijing
The first affiliated hospital of bengbu medical college
NOT_YET_RECRUITING
Bengbu
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital & Institute
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Jiangxi Maternal and Child Health Hospital
NOT_YET_RECRUITING
Nanchang
Guangxi Tumor Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
Tianjin Medical University Cancer Institute and Hospital
NOT_YET_RECRUITING
Tianjin
Contact Information
Primary
Jianmin Fang, Ph.D
Jianminfang@hotmail.com
+8610-58075763
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 116
Treatments
Experimental: Disitamab Vedotin + Zimberelimab
Disitamab Vedotin(RC48-ADC)with Zimberelimab arm
Related Therapeutic Areas
Sponsors
Leads: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov