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

NCT05684731 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-13

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • People's Hospital of Quzhou

    collaborator OTHER

  • Shenzhen Hua Yao Kang Ming Biopharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qinglei Gao, MD. PhD · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-06-01
Completion
2026-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05684731 on ClinicalTrials.gov