To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer

Onconic Therapeutics

Status and phase

Begins enrollment this month

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: JPI-547

Drug: Bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07370818

JPI-547-202

Details and patient eligibility

About

This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients

Enrollment

81 estimated patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [High-grade serous carcinoma (HGSC), Grade 2/3 endometrioid carcinoma]
Patients whose BRCA 1/2 gene mutation status and/or Homologous Recombination Deficiency (HRD) status.
Patients who received platinum-based chemotherapy followed by PARP inhibitor maintenance therapy,
Patients who had received chemotherapy before participating in the clinical trial and responded to platinum-based chemotherapy.
Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Individuals with confirmed adequate hematological, renal, and hepatic function (laboratory tests may be repeated once during the screening period)

Exclusion criteria

Patients with a history of severe drug hypersensitivity or hypersensitivity to the investigational drug, its components, or drugs within the same class.
Individuals with dysphagia
Patients with a confirmed specific medical history or a past surgical history.
Patients with specific comorbidities or medical abnormalities.
Pregnant women, lactating women, or women of childbearing potential who do not agree to use appropriate contraception during the clinical trial period and for 24 weeks after administration of the investigational medicinal product.
Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator.