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Cervical CancerPhase 2NCT07497074

JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer

A Phase 2 study testing JSKN033, Platinum and Bevacizumab in people with Cervical Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Cancer
What is being tested?
JSKN033, Platinum and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
2 sitesChina
Study dates
Apr 2026to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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:
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  • 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.
  • Pregnant and/or lactating women, or planning to become pregnant during the study period.
  • 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.
  • 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.
  • 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.
  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chunyan Lan, Dr. contact

086-020-87343009

lanchy@sysucc.org.cn

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Chunyan Lan, 086-020-87343468, lanchy@sysucc.org.cn

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310032

    Hanmei Lou, 086-0571-88122146, louhm@zjcc.org.cn

Other trials in China

About this study

Official title: 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.

Read the 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
Being tested
JSKN033, Platinum, Bevacizumab
Keywords
JSKN033, PD-L1, Antibody-Drug Conjugates
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN033Drug

    JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

  • PlatinumDrug

    JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

  • BevacizumabDrug

    JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

Study groups in NCT07497074
Study groupRoleWhat they receive
Safety run-in dose cohort 1ExperimentalJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 1 according to protocol
Receives: Drug: JSKN033; Drug: Platinum; Drug: Bevacizumab
Safety run-in dose cohort 2ExperimentalJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 2 according to protocol
Receives: Drug: JSKN033; Drug: Platinum; Drug: Bevacizumab
Dose expansion cohortExperimentalJSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at a selected dose level
Receives: Drug: JSKN033; Drug: Platinum; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of Treatment-Emergent Adverse Events (TEAEs)

    Measured: 21 days from the first dose

  2. Frequency and severity of Treatment-Related Adverse Events (TRAEs)

    Measured: 21 days from the first dose

  3. Frequency and severity of Serious Adverse Events (SAEs)

    Measured: 21 days from the first dose

  4. Objective Response Rate (ORR) as assessed by the investigator and IRC per RECIST 1.1.

    Measured: 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)

  1. Disease Control Rate (DCR)

    Measured: 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.

  2. Time to Response (TTR)

    Measured: 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

  3. Duration of Response (DoR)

    Measured: 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.

  4. Progression-Free Survival (PFS) as assessed by the investigator and IRC per RECIST 1.1

    Measured: 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.

  5. Overall Survival (OS)

    Measured: Assessed at approximately 24 months

  6. Maximum plasma concentration (Cmax) of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  7. Time to Cmax (Tmax) of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  8. Trough concentration (Ctrough) of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  9. Area under the plasma concentration-time curve of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  10. Volume of distribution (Vz/F) of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  11. Elimination half-life (t1/2) and clearance (CL/F) of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  12. Accumulation index of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  13. Mean residence time of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

  14. Incidence of anti-drug antibodies (ADA) of JSKN033

    Measured: From the enrollment until the end of study. Assessed up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497074
Sponsor's protocol ID
JSKN033-202
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JSKN033, Platinum and Bevacizumab in people with Cervical Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chunyan Lan, Dr. (086-020-87343009, lanchy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: 21 days from the first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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