NCT07497074

JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer

A Phase II Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Combination With Platinum-Based Chemotherapy With or Without Bevacizumab in Patients With Advanced Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an open-label, multicenter, Phase II clinical study conducted in China to evaluate the safety and efficacy of JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab in patients with advanced cervical cancer. The study consists of two phases: a safety run-in phase and a dose expansion phase. Enrolled subjects are patients with persistent, recurrent, or metastatic cervical cancer who have not received prior systemic therapy for recurrent or metastatic disease. All subjects will receive treatment with JSKN033 + cisplatin/carboplatin ± bevacizumab. All enrolled subjects will continue treatment until meeting any of the following treatment termination criteria: disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, early study termination, or other criteria specified in the protocol for treatment termination, whichever occurs first.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	JSKN033	JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
DRUG	Platinum	JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
DRUG	Bevacizumab	JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2028-06-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

2 sites across 1 country: China