JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer

March 23, 2026 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310032
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily participate and sign the informed consent form.
  2. Age ≥ 18 years old, male or female.
  3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  4. Expected survival ≥ 3 months.

  5. 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:

    1. Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
    2. No prior systemic therapy for recurrent or metastatic cervical cancer.
  6. At least one measurable lesion per RECIST 1.1 at baseline.
  7. Agree to provide recently archived or fresh tumor tissue samples.
  8. Adequate organ function.
  9. 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.
  10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.

Exclusion Criteria:

  1. 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.
  2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
  3. 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.
  4. Prior treatment with topoisomerase I inhibitors or antibody-drug conjugates containing topoisomerase I inhibitors.
  5. Inadequate washout period of previous therapy.
  6. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
  7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
  8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
  9. Gastrointestinal abnormalities with obvious clinical manifestations.
  10. Significant serous effusion.
  11. Active autoimmune diseases requiring systemic treatment.
  12. Uncontrolled infection.
  13. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
  14. History of allogeneic bone marrow or organ transplantation.
  15. Known allergy to any component of the study drug/platinum, or history of severe allergic reactions to other antibody drugs.
  16. Pregnant and/or lactating women, or planning to become pregnant during the study period.
  17. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
  18. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.
  19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and/or uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count > 20×10⁹/L), cachexia manifestations, etc.
  20. Known contraindications to bevacizumab or allergy to its components, or the medical conditions affecting its safe use (Note: Applicable only to subjects planned to receive bevacizumab).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Safety run-in dose cohort 1
JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 1 according to protocol
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
Experimental: Safety run-in dose cohort 2
JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 2 according to protocol
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
Experimental: Dose expansion cohort
JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at a selected dose level
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Frequency and severity of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 21 days from the first dose
21 days from the first dose
Frequency and severity of Treatment-Related Adverse Events (TRAEs)
Time Frame: 21 days from the first dose
21 days from the first dose
Frequency and severity of Serious Adverse Events (SAEs)
Time Frame: 21 days from the first dose
21 days from the first dose
Objective Response Rate (ORR) as assessed by the investigator and IRC per RECIST 1.1.
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: 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.
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)
Time Frame: 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
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)
Time Frame: 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.
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
Time Frame: 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.
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)
Time Frame: Assessed at approximately 24 months
Assessed at approximately 24 months
Maximum plasma concentration (Cmax) of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Time to Cmax (Tmax) of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Trough concentration (Ctrough) of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Area under the plasma concentration-time curve of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Volume of distribution (Vz/F) of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Elimination half-life (t1/2) and clearance (CL/F) of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Accumulation index of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Mean residence time of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.
Incidence of anti-drug antibodies (ADA) of JSKN033
Time Frame: From the enrollment until the end of study. Assessed up to 24 months.
From the enrollment until the end of study. Assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSKN033-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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