The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RC88 monotherapy in subjects with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
2.0 mg/kg Q3W IV
Overall Response Rate (ORR) by Independent Review Committee (IRC)
The proportion of subjects whose BOR is a confirmed CR or PR. Tumor response will be evaluated by IRC using RECIST v.1.1.
Time frame: Up to approximately 2 years
Overall Response Rate (ORR) by investigator
The proportion of subjects whose BOR is a confirmed CR or PR. Tumor response will be evaluated by investigator using RECIST v.1.1.
Time frame: Up to approximately 2 years
Duration of response (DOR) by Independent Review Committee (IRC)
The duration from first documentation of response (CR or PR) until the time of first documentation of disease progression or death. Tumor response will be evaluated by IRC using RECIST v.1.1.
Time frame: Up to approximately 2 years
Duration of response (DOR) by investigator
The duration from first documentation of response (CR or PR) until the time of first documentation of disease progression or death. Tumor response will be evaluated by the investigator using RECIST v.1.1.
Time frame: Up to approximately 2 years
Progression-free survival (PFS) by Independent Review Committee (IRC)
The duration from first dose to disease progression or death as assessed by IRC using RECIST v1.1 criteria.
Time frame: Up to approximately 2 years
Progression-free survival (PFS) by investigator
The duration from first dose to disease progression or death as assessed by the investigator using RECIST v1.1 criteria.
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Xingtai People's Hospital
Xingtai, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
...and 20 more locations
Overall survival (OS)
The duration from the date of the first dose of study treatment to the date of death.
Time frame: Up to approximately 2 years
CA-125 relieve defined by GCIG
Serum CA125 Assessment defined by GCIG
Time frame: Up to approximately 2 years
The peak and trough concentrations of RC88 binding antibody (ADC), total antibody (TAb) and free MMAE
The peak and trough concentrations of RC88 binding antibody (ADC), total antibody (TAb) and free MMAE will be detected.
Time frame: Up to approximately 2 years
Incidence of Anti-Drug Antibodies (ADA), titers, and/or neutralizing antibodies (NAb) Rate etc.
Incidence of Anti-Drug Antibodies (ADA), titers, and/or neutralizing antibodies (NAb) Rate etc.will be detected.
Time frame: Up to approximately 2 years
Safety: The types, incidence, correlation, and severity of various adverse events (AES), as well as the types, incidence, and severity of laboratory abnormalities
The types, incidence, correlation, and severity of various adverse events (AES), as well as the types, incidence, and severity of laboratory abnormalities will be detected.
Time frame: Up to approximately 2 years