Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

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Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Peritoneal Neoplasms

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

RC88 for Injection Arm all patients will receive single-agent RC88 at 2.0 mg/kg administered on Day 1 of every 3-week cycle (Q3W).

RC88

Jianmin Fang, Ph.D

Yuzhi Li, M.D

Weidong Zhao, M.D

Yuankai Shi, Ph.D

Jianliu Wang, M.D

Xiuwei Chen, M.D

Ruixia Guo, M.D

Hui Qiu, M.D

Yi Huang, M.D

Quan Li, M.D

Jing Wang, M.D

Lijing Lijing, M.D

Ying Liu, M.D

Jie Jiang, M.D

Qi Dang, M.D

Liang Chen, M.D

Beihua Kong, M.D

Xin Lu, M.D

Wei Wang, M.D

Ke Wang, M.D

Hongying Yang, M.D

Xuejun Chen, M.D

Aijun Yu, M.D

Huafeng Shou, M.D

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).

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).

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 Pharmacokenetics of RC88 Monotherapy in Platinum-resistant Reccurent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) .The objective response rate will be mainly analyzed by the Independent Review Committee (IRC) by according to the RECIST 1.1 standard tumor evaluation.

Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) . ORR by the investigator will be analyzed.

Duration of response was defined as the time interval between confirmed initial remission (CR or PR) disease progression (PD) or death, whichever is earlier. Evaluation by the Independent Review Committee (IRC) will be performed.

Duration of response was defined as the time interval between confirmed initial remission (CR or PR) as assessed by the investigator and investigator-assessed disease progression (PD) or death, whichever is earlier.

Progression-free survival (PFS) by Independent Review Committee (IRC) was defined as the time interval between the first administration of RC88 and IRC-assessed imaging disease progression (PD) or death, whichever is earlier

Progression-free survival (PFS) by investigator was defined as the time interval between the first administration of RC88 and investigator-assessed imaging disease progression (PD) or death, whichever is earlier

Overall survival(OS) was defined as the time interval between the first administration of RC88 and death.

Cmax will be derived from the PK blood samples collected.

Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

Immunohistochemistry was used to detect the expression of MSLN in tissue sections, and the results were used for later retrospective analysis

RemeGen Co., Ltd.

Subjects will receive intravenous infusion of RC88 once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs

Xiaohong Su, M.D

Yuankai Shi, M.D

Ziping Wang, M.D

Peng Zhang, M.D

Ying Cheng, M.D

DongYun Zhu, M.D

Yan Zhang, M.D

XiaoRong Dong, M.D

Xiaohong Su, M.D.

Yuankai Shi, M.D.

Ziping Wang, M.D.

Peng Zhang, M.D.

DongYun Zhu, M.D.

Yan Zhang, M.D.

XiaoRong Dong, M.D.

The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Incidence of DLT (dose limiting toxicity) of RC88

Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Phase I:Participants will be allocated to one of the following dose groups: 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC88-ADC followed by 21 days of dose limited toxicity (DLT) observation period.

Phase IIa indication exploration

Suxia Luo, M.D.

BaoRui LI

Yuguang Zhao, M.D.

Jiuwei Cui, M.D.

This was a multicenter, open, multi-cohort extended PHASE I/IIa study, consisting of 2 phases:Phase I (Phase I dose escalation) and Phase II (Phase IIa multi-cohort extension). The objective of this study was to evaluate safety, tolerability, pharmacokinetic characteristics, and initial efficacy in malignant pleural mesothelioma and MSLN in advanced malignant solid tumors.

Phase I dose escalation phase：This study predicted a total of 6 dose groups, 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg.

Phase IIa efficacy exploration phase:This phase is the multi-cohort indication expansion phase. Based on the data obtained in phase I, chose an appropriate dose continue to explore multi-cohort indications, including confirmed malignancy Pleural mesothelioma and MSLN expression were determined.

A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors

To Evaluate the Safety of RC88 for Injection in Patients With Advanced Malignant Solid Tumors,Multicenter, Open, Multi-cohort Extension of Efficacy and Pharmacokinetic Characteristics Phase I /IIa Clinical Study

Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03

The dose level in which \>= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.

Tmax will be derived from the PK blood samples collected.

AUC will be derived from the PK blood samples collected.

Ctrough will be derived from the PK blood samples collected.

t1/2 will be derived from the PK blood samples collected.

CL will be derived from the PK blood samples collected.

1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks

Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks

Sintilimab Injection

Heping Liu

Shi Yuankai, M.D.

This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours

A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours

Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab

Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer	NCT06173037	Primary Periton... Fallopian Tube Epithelial Ovar...	RC88	18 Years -	RemeGen Co., Ltd.
A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours	NCT05508334	Advanced Solid ...	RC88	18 Years - 70 Years	RemeGen Co., Ltd.
A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors	NCT04175847	Solid Tumor	RC88	18 Years - 70 Years	RemeGen Co., Ltd.
A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours	NCT05804526	Advanced Solid ...	RC88 Sintilimab Inje...	18 Years - 70 Years	RemeGen Co., Ltd.
RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer	NCT06173037	Primary Periton... Fallopian Tube Epithelial Ovar...	RC88	18 Years -	RemeGen Co., Ltd.

Spots Global Cancer Trial Database for rc88

Every month we try and update this database with for rc88 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rc88

Every month we try and update this database with for rc88 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rc88 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.