JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Study ID
- NCT07497074
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- JSKN033 — DRUGJSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
- Platinum — DRUGJSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
- Bevacizumab — DRUGJSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Study Details
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.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Mar 2026
- Primary completion
- Oct 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 78 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Safety run-in dose cohort 1JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 1 according to protocol
- Experimental: Safety run-in dose cohort 2JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 2 according to protocol
- Experimental: Dose expansion cohortJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at a selected dose level
Primary Outcome Measure
Frequency and severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 21 days from the first dose ]
Central Contacts
- Chunyan Lan, Dr.086-020-87343009
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