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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

78

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

April 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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