RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
NCT ID: NCT06173037
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2024-01-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RC88 for Injection
Participants will receive RC88 2.0 mg/kg every 3 weeks (Q3W)
RC88
2.0 mg/kg Q3W IV
Interventions
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RC88
2.0 mg/kg Q3W IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female subjects aged 18 years or older at the time of signing the Informed Consent Form;
3. Histology confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer;
4. Must be newly developed platinum-resistant (Must not have received systemic therapy after developing platinum resistance status);
5. Received at least 3 prior lines of systemic therapies；
6. Imaging evidence of disease progression during or at the end of last-line therapy;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
8. Life expectancy of at least 12 weeks;
9. Subjects are willing to provide archival tumor tissue samples or accept a low-risk routine medical procedure to collect the fresh biopsy sample for immunohistochemical (IHC) MSLN testing;
10. Measurable lesion according to RECIST v1.1；
11. The interval between previous focal radiotherapy and the first dose should be at least 2 weeks；
12. Have laboratory tests that meet the relevant requirements to demonstrate adequate organ function;
13. Subjects of childbearing potential are required to use effective contraception from the time of informed consent and continuing through 6 months after the final dose of study intervention; Fertile subjects included those who were not menopausal or had been menopausal for less than 2 years and had not undergone bilateral adnexectomy or hysterectomy；Subjects of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study intervention.
Exclusion Criteria
2. Subjects with asymptomatic brain metastases who have received prior treatment may participate in this study if they meet all the following criteria:
* Only supratentorial and/or cerebellar metastases are present.
* Corticosteroids should be discontinued for at least 7 days prior to the first dose;
* No disease progression is observed on imaging from completion of brain-directed therapy until randomization compared to pre-treatment imaging (at least 4 weeks interval).
* Subjects must undergo radiotherapy and/or surgery for brain metastases if new asymptomatic brain metastases are detected during screening period.
3. 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 recurrence；
4. Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to Grade 0 or 1 by NCI CTCAE 5.0;
5. 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;
6. Subjects who have received herbal or proprietary Chinese medicines for tumor control within 14 days prior to the first dose;
7. Subjects who have received previous mesothelin target-related drugs or MMAE, MMAF, DM1, DM4 and other microtubule inhibitor ADCs；
8. Subjects with clinical symptoms or signs of gastrointestinal obstruction;
9. History of cirrhotic liver disease (Child-Pugh Class B or C);
10. 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 dose；
11. Major surgery within 4 weeks and no fully recovered prior to the first dose or anticipation of surgery；
12. Patients with active or progressive infection that requiring systemic therapy within 14 days prior to first dose, such as active tuberculosis;
13. serum virological testing (based on study center normal values)
* Positive results of Hepatitis B virus surface antigen (HBsAg) should be further tested for HBV DNA, HBV DNA \> 200IU/ml or 2000 copies /ml cannot be enrolled. However, if subjects received nucleotide-based antiviral therapy and test result below the criteria above, they could be enrolled;
* Positive results of Hepatitis C antibody (HCVAb) (HCV RNA\>103 copies/ml) cannot be enrolled. However, if subjects received nucleotide-based antiviral therapy and the test result below the criteria above, they could be enrolled;
* Positive results for human immunodeficiency virus antibody (HIVAb).
14. Subjects with prior allogeneic haematopoietic stem cell transplantation or solid organ transplantation, or those who are waiting for organ transplantation;
15. Uncontrolled or significant cardiovascular and cerebrovascular diseases;
16. A history of interstitial lung disease requiring treatment or currently having a severe pulmonary disease, including but not limited to interstitial lung disease;
17. 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 study；
18. 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 examinations；
19. 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;
20. 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 study；
21. Known psychiatric or substance abuse disorders that may have an impact on compliance with the study requirements.
22. Pregnant and/or breast-feeding women；
23. 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.
18 Years
FEMALE
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuankai Shi, M.D
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beihua Kong, M.D
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Jie Jiang, M.D
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
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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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Cancer Hospital, Shandong Cancer Institute
Jinan, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shangdong, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The West China Second University Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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RC88-C008
Identifier Type: -
Identifier Source: org_study_id
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