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A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions

ConditionHigh-grade Cervical Intraepithelial Lesions
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age must be 18 years old or above;

During the screening period, the research center confirmed participants with HPV type 16 and/or type 18 cervical infection;

During screening, the research center confirmed histological evidence of cervical HSIL (CIN grade 2~CIN3) (lesions may be obtained within 3 months prior to the first study treatment);

Colposcopy results at each research center during the screening period must meet the following conditions: 1) Fully visible squamous-columnar epithelial junction (type I or type II transformation zone), with fully visible upper white acetic acid epithelial or suspected CIN lesions; 2) Cervical lesions can be touched and sampled by biopsy instruments, and the cervical lesions are sufficiently large to ensure visible lesions remain for observation during the study period;

Disqualifiers

Screening combined with other high-risk HPV subtypes (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68);

Cases with VIN/VAIN/AIN or AIS or other lesions should be excluded.

During screening, cytological or histopathological examination yields any of the following: AIS, AGC-FN, invasive cancer, etc.;

HSIL treatment within 4 weeks prior to the first vaccination;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYS6026

    Biological/Vaccine

    Administration continued until D168

  • Placebo

    Biological/Vaccine

    Administration continued until D168

Treatment groups

175 Participants
are divided into 4 treatment groups
Group A: SYS6026, dose1,subcutaneous injection, three primary immunizations and one boosterExperimental treatment 1 intervention
Group B: SYS6026, dose2,subcutaneous injection, three primary immunizations and one boosterExperimental treatment 1 intervention
Group C: SYS6026, dose3,subcutaneous injection, three primary immunizations and one boosterExperimental treatment 1 intervention
Group D: Placebo, subcutaneous injection, three primary immunizations and one boosterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants whose pathology had resolved/remission to CIN1 and HPV16/18 negative at 36 weeks post-vaccination (independent pathology review)

Time frame
24 months

Secondary outcomes

1

Proportion of participants whose pathology had regression/downgraded at 36 weeks after first vaccination (independent pathology review)

Time frame
24 months
2

Proportion of participants with pathological normal conditions at 36 weeks post-vaccination (independent pathology review)

Time frame
24 months
3

The incidence and severity of AE and SAE during the study period

Time frame
24 months
4

Serum titers of anti-HPV16 E6/E7 and anti-HPV18 E6/E7 binding antibodies were assessed

Time frame
24 months

Other outcomes

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: