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
1 other identifier
interventional
78
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
March 27, 2026
March 1, 2026
1.5 years
March 10, 2026
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Frequency and severity of Treatment-Emergent Adverse Events (TEAEs)
21 days from the first dose
Frequency and severity of Treatment-Related Adverse Events (TRAEs)
21 days from the first dose
Frequency and severity of Serious Adverse Events (SAEs)
21 days from the first dose
Objective Response Rate (ORR) as assessed by the investigator and IRC per RECIST 1.1.
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
Secondary Outcomes (14)
Disease Control Rate (DCR)
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
Time to Response (TTR)
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months
Duration of Response (DoR)
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
Progression-Free Survival (PFS) as assessed by the investigator and IRC per RECIST 1.1
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
Overall Survival (OS)
Assessed at approximately 24 months
- +9 more secondary outcomes
Study Arms (3)
Safety run-in dose cohort 1
EXPERIMENTALJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 1 according to protocol
Safety run-in dose cohort 2
EXPERIMENTALJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 2 according to protocol
Dose expansion cohort
EXPERIMENTALJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at a selected dose level
Interventions
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Eligibility Criteria
You may qualify if:
- 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.
- Histologically or cytologically confirmed persistent, recurrent, or metastatic (FIGO stage IVB) cervical cancer unsuitable for curative surgery and/or curative radiotherapy, meeting the following criteria:
- Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- No prior systemic therapy for recurrent or metastatic cervical cancer.
- At least one measurable lesion per RECIST 1.1 at baseline.
- Agree to provide recently archived or fresh tumor tissue samples.
- Adequate organ function.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
- Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
You may not qualify if:
- 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.
- Inadequate washout period of previous therapy.
- Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
- Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
- Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Gastrointestinal abnormalities with obvious clinical manifestations.
- Significant serous effusion.
- Active autoimmune diseases requiring systemic treatment.
- Uncontrolled infection.
- Toxicity of previous anti-tumor treatment has not fully or partially recovered.
- History of allogeneic bone marrow or organ transplantation.
- Known allergy to any component of the study drug/platinum, or history of severe allergic reactions to other antibody drugs.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 27, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share