Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06173037
Study type Interventional
Source RemeGen Co., Ltd.
Contact Jianmin Fang, Ph.D
Phone +8610-58075763
Email Jianminfang@hotmail.com
Status Not yet recruiting
Phase Phase 2
Start date December 31, 2023
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03393884 - Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) Phase 1/Phase 2
Completed NCT04546373 - Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Active, not recruiting NCT05456685 - IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer Phase 2
Recruiting NCT05494580 - Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer Phase 1/Phase 2
Completed NCT02928549 - Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Completed NCT02480374 - Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer Phase 1
Completed NCT01899599 - PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Phase 2
Completed NCT01219777 - Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian Phase 1
Completed NCT00959582 - Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143) Phase 1
Terminated NCT00418093 - Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma Phase 2
Completed NCT00314678 - Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer Phase 2
Not yet recruiting NCT04889495 - A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
Completed NCT01666444 - VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Phase 2
Recruiting NCT05665023 - Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma Phase 2
Terminated NCT01744821 - Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer N/A
Active, not recruiting NCT01220154 - Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer Phase 1
Completed NCT03213964 - Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int Phase 1
Not yet recruiting NCT06063070 - First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer Phase 2
Completed NCT01204749 - TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer Phase 3
Completed NCT01253681 - Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer Phase 1