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SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

ConditionCervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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)；

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYS6002

    Drug

    SYS6002，intravenous injection

  • Investigator's Choice of Chemotherapy

    Drug

    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).

Treatment groups

412 Participants
are divided into 2 treatment groups
Group A: SYS6002Experimental treatment 1 intervention
Group B: ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
Up to 3.5 years

Secondary outcomes

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.

Time frame
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.

Time frame
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).

Time frame
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.

Time frame
Up to 3.5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: