RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

A Multicenter, Single-arm, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC88 Monotherapy in Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

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 Overview

• Status: Completed
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Cancer
• Intervention / Treatment: Drug: RC88

Detailed Description

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of RC88 monotherapy in subjects with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (PROC). Approximately 88 eligible patients will be enrolled，and all patients will receive single-agent RC88 at 2.0 mg/kg administered on Day 1 of every 3-week cycle (Q3W). Patients will continue to receive RC88 until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first).

Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 1 week) from Cycle 1 Day 1 (C1D1) for the first 48 weeks then every 12 weeks (± 1 week) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first).

All patients who discontinue RC88 will be followed for survival every 3 months (± 2 weeks) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (whichever comes first).

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
  • Hebei
    • Xingtai, Hebei, China, 054031
      • Xingtai People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430023
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital
    • Changchun, Jilin, China, 130031
      • The First hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital, Shandong Cancer Institute
    • Qingdao, Shandong, China, 266042
      • Qingdao Central Hospital
  • Shangdong
    • Jinan, Shangdong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Obstetrics & Gynecology Hospital of Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Second Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • The West China Second University Hospital of Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute & Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Agree to participate in the study and sign an Informed Consent Form;
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:

1. 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;

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RC88 for Injection; Participants will receive RC88 2.0 mg/kg every 3 weeks (Q3W)	Drug: RC88; 2.0 mg/kg Q3W IV; Other Names: RC88 for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: RC88-C008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No