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

NCT06173037 | Completed Phase 2

• 1 other identifier: RC88-C008
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Primary Peritoneal Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer

Keywords

Primary Peritoneal Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Overall Response Rate (ORR) by investigator

  Up to approximately 2 years

• Duration of response (DOR) by Independent Review Committee (IRC)

  Up to approximately 2 years

• Duration of response (DOR) by investigator

  Up to approximately 2 years

• Progression-free survival (PFS) by Independent Review Committee (IRC)

  Up to approximately 2 years

• Progression-free survival (PFS) by investigator

  Up to approximately 2 years

Study Arms (1)

RC88 for Injection

EXPERIMENTAL

Participants will receive RC88 2.0 mg/kg every 3 weeks (Q3W)

Drug: RC88

Interventions

RC88 DRUG

2.0 mg/kg Q3W IV

Also known as: RC88 for Injection

RC88 for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to participate in the study and sign an Informed Consent Form;
• Female subjects aged 18 years or older at the time of signing the Informed Consent Form;
• Histology confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer;
• Must be newly developed platinum-resistant (Must not have received systemic therapy after developing platinum resistance status);
• Received at least 3 prior lines of systemic therapies；
• Imaging evidence of disease progression during or at the end of last-line therapy;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy of at least 12 weeks;
• 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;
• Measurable lesion according to RECIST v1.1；
• The interval between previous focal radiotherapy and the first dose should be at least 2 weeks；
• Have laboratory tests that meet the relevant requirements to demonstrate adequate organ function;
• 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.

You may not qualify if:

• 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:
• 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.
• 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；
• 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 ADCs；
• 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 dose；
• Major surgery within 4 weeks and no fully recovered prior to the first dose or anticipation of surgery；

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (30)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Xingtai People's Hospital

Xingtai, Hebei, 054031, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430023, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130031, China

Location

Shandong Cancer Hospital, Shandong Cancer Institute

Jinan, Shandong, 250117, China

Location

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

Location

Qilu Hospital of Shandong University

Jinan, Shangdong, 250012, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

The West China Second University Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 15, 2023
• Study Start: January 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)