NCT05684731

Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer

A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of KM1 Oncolytic Vaccinia Virus Injection Combined With Chemotherapy in Subjects With Recurrent or Refractory Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if KM1 is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer, and explore the Recommend Phase 2 Dose (RP2D) of KM1 in the treatment of patients with recurrent or refractory ovarian cancer.

Detailed description

Oncolytic virus therapy is a kind of immunotherapy that can selectively infect and kill tumor cells without damaging normal cells. It has shown good therapeutic effects in the treatment of various types of tumors. KM1 is a genetically modified recombinant vaccinia virus, which has good therapeutic effect on many solid tumors, including ovarian cancer. This study includes Phase Ia and Phase Ib. In the Phase Ia study, subjects will receive three doses intraperitoneal infusion of KM1 followed by chemotherapy. In the Phase Ib study, subjects will receive six doses intraperitoneal infusion of KM1 preceding chemotherapy. Subjects will be followed in the study for 6 months after last dose of chemotherapy.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	KM1	Administer via intraperitoneal infusion for 3 or 6 doses Q3D.
DRUG	Chemotherapy	Physician's Choice of carboplatin (preferred) or cisplatin，gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin，with or without bevacizumab. Administer beginning in Week 5 or Week 6.

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-01-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: China