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RECRUITING
NCT05684731
PHASE1

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

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-02-01

Completion Date

2026-06-01

Last Updated

2024-08-13

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

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

Wuhan, Hubei, China