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Primary Peritoneal CancerPhase 2NCT06173037

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

A Phase 2 study testing RC88 in people with Primary Peritoneal Cancer and Fallopian Tube Cancer, run by RemeGen Co., Ltd. at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
RC88
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
30 sitesChina
Study dates
19 Jan 2024to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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；
  • 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)
  • 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).
  • 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 study；
  • 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；
  • 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 study；
  • Known psychiatric or substance abuse disorders that may have an impact on compliance with the study requirements.
  • Pregnant and/or breast-feeding women；
  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130031

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • The West China Second University Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Shandong Cancer Hospital, Shandong Cancer Institute

    Jinan, Shandong, 250117

  • Qilu Hospital of Shandong University

    Jinan, Shangdong, 250012

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200011

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430023

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • Xingtai People's Hospital

    Xingtai, Hebei, 054031

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: 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.

Being tested
RC88
Keywords
Primary Peritoneal Cancer, Fallopian Tube Cancer, Epithelial Ovarian Cancer
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC88Drug

    Also called RC88 for Injection

    2.0 mg/kg Q3W IV

Study groups in NCT06173037
Study groupRoleWhat they receive
RC88 for InjectionExperimentalParticipants will receive RC88 2.0 mg/kg every 3 weeks (Q3W)
Receives: Drug: RC88

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 2 years

Secondary outcomes (10)

  1. 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.

    Measured: Up to approximately 2 years

  2. 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.

    Measured: Up to approximately 2 years

  3. 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.

    Measured: Up to approximately 2 years

  4. 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.

    Measured: Up to approximately 2 years

  5. 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.

    Measured: Up to approximately 2 years

  6. Overall survival (OS)

    The duration from the date of the first dose of study treatment to the date of death.

    Measured: Up to approximately 2 years

  7. CA-125 relieve defined by GCIG

    Serum CA125 Assessment defined by GCIG

    Measured: Up to approximately 2 years

  8. 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.

    Measured: Up to approximately 2 years

  9. 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.

    Measured: Up to approximately 2 years

  10. 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.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start19 Jan 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06173037
Sponsor's protocol ID
RC88-C008
Status last verified
Dec 2025
First submitted
29 Nov 2023
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC88 in people with Primary Peritoneal Cancer and Fallopian Tube Cancer, run by RemeGen Co., Ltd. at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) by Independent Review Committee (IRC) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06173037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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