JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

The goal of this clinical trial is to learn if the therapy of JSKN033 plus chemotherapy with or with bevacizumab is safe to treat patients with advanced cervical cancer. It will also learn about the antitumor activity and pharmacokinetic/ pharmacodynamic profiles of this therapy.

Eligibility criteria

Qualifiers

Voluntarily participate and sign the informed consent form.

Age ≥ 18 years old, male or female.

Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Expected survival ≥ 3 months.

Disqualifiers

Complicated with other malignant tumors within 3 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk.

History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.

Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.

Prior treatment with topoisomerase I inhibitors or antibody-drug conjugates containing topoisomerase I inhibitors.

Trial design

Treatments tested in this trial

  • JSKN033
  • Platinum
  • Bevacizumab

Treatment groups

78 Participants
are divided into 3 treatment groups