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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC88 for Injection | Experimental | Participants will receive RC88 2.0 mg/kg every 3 weeks (Q3W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC88 | Drug | 2.0 mg/kg Q3W IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years |
| Duration of response (DOR) by Independent Review Committee (IRC) |
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Inclusion Criteria:
Exclusion Criteria:
The presence of clinically uncontrollable third-space fluids, such as massive pleural effusion or pericardial effusion accompanied by clinical symptoms or requiring symptomatic management; and ascites that cannot be effectively controlled with treatment;
Subjects with asymptomatic brain metastases who have received prior treatment may participate in this study if they meet all the following criteria:
Subjects with a history of other invasive malignancies within 3 years prior to the first dose, except for adequately treated papillary thyroid carcinoma, basal cell or squamous cell skin cancers without evidence of recurrence, and other adequately treated carcinoma in situ without evidence of disease recurrenceï¼›
Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to Grade 0 or 1 by NCI CTCAE 5.0;
Subjects who have received systemic anti-tumor therapy (including chemotherapy, targeted therapy, biologic therapy, hormonal therapy, etc.) within 28 days or 5 half-lives of prior therapy (whichever is shorter) prior to first dose;
Subjects who have received herbal or proprietary Chinese medicines for tumor control within 14 days prior to the first dose;
Subjects who have received previous mesothelin target-related drugs or MMAE, MMAF, DM1, DM4 and other microtubule inhibitor ADCsï¼›
Subjects with clinical symptoms or signs of gastrointestinal obstruction;
History of cirrhotic liver disease (Child-Pugh Class B or C);
Subjects with immunodeficiency diseases, currently receiving systemic glucocorticoid therapy (dose>10 mg/d of prednisone or equivalent dose among drugs in the same class), or receiving immune suppressant therapy within 7 days prior to the first doseï¼›
Major surgery within 4 weeks and no fully recovered prior to the first dose or anticipation of surgeryï¼›
Patients with active or progressive infection that requiring systemic therapy within 14 days prior to first dose, such as active tuberculosis;
serum virological testing (based on study center normal values)
Subjects with prior allogeneic haematopoietic stem cell transplantation or solid organ transplantation, or those who are waiting for organ transplantation;
Uncontrolled or significant cardiovascular and cerebrovascular diseases;
A history of interstitial lung disease requiring treatment or currently having a severe pulmonary disease, including but not limited to interstitial lung disease;
In the investigator's opinion, any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory findings, that raise reasonable suspicion of a disease or condition affecting the interpretation of the study results or placing the patient at high risk of participating in the studyï¼›
Subjects with active corneal disease and those who, in the judgement of the ophthalmologist, are unsuitable for inclusion by funduscopic examination and other ocular related examinationsï¼›
Subjects with known allergies to RC88 or its excipients or have had a history of severe allergic reactions to the other monoclonal antibodies or chemotherapies;
Subjects who have received a live or live-attenuated vaccine within 4 weeks prior to the first dose or plan to receive the above vaccines during the studyï¼›
Known psychiatric or substance abuse disorders that may have an impact on compliance with the study requirements.
Pregnant and/or breast-feeding womenï¼›
The subject's compliance are estimated to be insufficient to participate in this study, or other factors that, in the investigator's opinion, make the subjects unsuitable for participation of this study.
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, M.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Beihua Kong, M.D | Qilu Hospital of Shandong University | Principal Investigator |
| Jie Jiang, M.D | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| Cancer Hospital Chinese Academy of Medical Sciences |
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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. |
| 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. | 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. | 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. | Up to approximately 2 years |
| Overall survival (OS) | The duration from the date of the first dose of study treatment to the date of death. | Up to approximately 2 years |
| CA-125 relieve defined by GCIG | Serum CA125 Assessment defined by GCIG | 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. | 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. | 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. | Up to approximately 2 years |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Xingtai People's Hospital | Xingtai | Hebei | 054031 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430023 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Xiangyang Central Hospital | Xiangyang | Hubei | 441021 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410031 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130031 | China |
| Shandong Cancer Hospital, Shandong Cancer Institute | Jinan | Shandong | 250117 | China |
| Qingdao Central Hospital | Qingdao | Shandong | 266042 | China |
| Qilu Hospital of Shandong University | Jinan | Shangdong | 250012 | China |
| Obstetrics & Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | 200011 | China |
| Second hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| The West China Second University Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650118 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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