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Cervical CancerPhase 3NCT07230626

SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

A Phase 3 study testing SYS6002 and Investigator's Choice of Chemotherapy in people with Cervical Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

Not yet recruiting

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

Official record
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Trial summary

This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
SYS6002 and Investigator's Choice of Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
No sites listed yet
Study dates
20 Nov 2025to 1 Jul 2028
Phase
Phase 3
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients aged 18-75 years (inclusive);
  • 2. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent;
  • 3. Subject must have received a platinum-based chemotherapy with anti-PD-(L)1 agent and if was received administered in the adjuvant/neoadjuvant setting subject must have progressed during treatment or within 6 months of treatment completion；received no more than 2 prior systemic therapy in the metastatic/recurrent setting; must have experienced radiographic progression during or after the last treatment regimen;
  • 4. An archival tumor tissue sample or a fresh tissue sample should be provided;
  • 5. Subjects must have measurable disease according to RECIST (version 1.1);
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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  • 7. Life expectancy of ≥ 3 months;
  • 8. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;
  • 9.Sexually active fertile subjects must agree to use methods of contraception during the study and at least7 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;
  • 10.Willing to participate in the study, understand the study procedures, and sign a written informed consent form.

Who cannot join

  • 1. Has other histologies not mentioned as part of the inclusion criteria 2;
  • 2. Active central nervous system metastases or leptomeningeal metastasis;
  • 3. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；
  • 4. Any serious and/or uncontrolled concurrent illness that may interfere with patient's particiation in the study:
  • Participants with a history of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval > 480 ms by Fridericia method (Fridericia formula: QTcF = QT/RR^0.33, RR = 60/heart rate); With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) < 50% in the tests and examinations during the screening period; Cerebrovascular Accident; Participants with poorly controlled hypertension on medication, with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg;
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  • Other clinically significant diseases:
  • HbA1c > 8%; Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness; Grade ≥2 neuropathy prior to randomization; Severe infection within 4 weeks prior to randomization; active infection requiring systemic antibiotics, antiviral, or antifunga therapy within 2 weeks prior to randomization; Active HBV or HCV infection; History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; History of another malignancy within 3 years prior to randomization; History of interstitial lung disease (ILD) / non-infectious pneumonia, or current ILD/non-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor; History of genital tract fistula, except for whose perforations or fistulas that have been treated with resection or repair, and are considered by the investigator to be healed or in remission; Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;
  • 5. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;
  • 6. Allergy to any component of SYS6002, or humanized monoclonal antibodies;
  • 7. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

About this study

Official title: A Randomized, Open-Label, Controlled, Multicenter Phase 3 Trial of SYS6002 Versus Chemotherapy of Physician's Choice in Recurrent or Metastatic Cervical Cancer After Platinum-containing Chemotherapy and Anti-PD-(L)1 Agent Therapy

This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1/L1 inhibitor therapy

Conditions
Cervical Cancer
Being tested
SYS6002, Investigator's Choice of Chemotherapy
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.

  • SYS6002Drug

    SYS6002，intravenous injection

  • Investigator's Choice of ChemotherapyDrug

    Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic cervical cancer, including topotecan (1.2 mg/m^2 of by IV on Days 1 to 5, every 21 days), gemcitabine (1000 mg/m^2 by IV on Days 1 and 8, every 21 days), pemetrexed (500 mg/m^2 by IV on Day 1, every 21 days), or docetaxel (75 mg/m^2 by IV on Day 1, every 21 days).

Study groups in NCT07230626
Study groupRoleWhat they receive
SYS6002ExperimentalSYS6002 monotherapy
Receives: Drug: SYS6002
ChemotherapyActive comparatorInvestigator's choice of one chemotherapy treatment (topotecan, gemcitabine, pemetrexed, or docetaxel)
Receives: Drug: Investigator's Choice of Chemotherapy

What is being measured

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

  1. Overall Survival

    Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive

    Measured: Up to 3.5 years

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

    Measured: Up to 3.5 years

  2. Duration of Response (DOR)

    DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to 3.5 years

  3. Disease Control Rate (DCR)

    The percentage of participants who experience a best response of CR, PR or stable disease (SD).

    Measured: Up to 3.5 years

  4. Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.

    Measured: Up to 3.5 years

  5. Incidence of adverse events

    Measured: Up to 3.5 years

  6. Incidence of Anti-Drug Antibody (ADA)

    Measured: Up to 3.5 years

  7. Blood concentration of SYS6002

    Measured: Up to 3.5 years

Timeline

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

  1. First posted17 Nov 2025
  2. Study start20 Nov 2025 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jul 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants in this trial will be randomly assigned to one of two groups.
Masking
None (open label)
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230626
Sponsor's protocol ID
SYS6002-006
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
17 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYS6002 and Investigator's Choice of Chemotherapy in people with Cervical Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

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 10 inclusion and 11 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to 3.5 years). 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 NCT07230626.

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 17 Nov 2025.

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