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This is a Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study to evaluate the efficacy of WX390 in combination with toripalimab versus investigator's choice of therapy in patients with recurrent or metastatic cervical cancer who have failed at least one prior platinum-based systemic therapy, as assessed by overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX390 1.1mg + Toripalimab 240mg | Experimental | Participants will receive WX390 continuous oral dosing (1.1 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). |
|
| Investigator's Choice of Chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX390 1.1mg + Toripalimab 240mg | Drug | Participants will receive WX390 continuous oral dosing (1.1 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in cervical cancer patients who have failed at least one prior line of platinum-based therapy | through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy including ORR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria. | through study completion, an average of 1 year | |
| Adverse Events (AEs), including type, incidence, grading (assessed according to the NCI-CTCAE v5.0 criteria), severity, and relationship to the investigational drug, among others. |
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Inclusion Criteria:
The subject voluntarily participates in this clinical study, has provided signed informed consent prior to the initiation of any screening procedures, and is able to understand and comply with the study requirements.
Aged 18 to 75 years (inclusive, calculated on the day of signing the informed consent form).
Histologically or cytologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Not eligible for curative treatment with surgery, radiotherapy, or chemoradiotherapy.
Willing to undergo a biopsy during the screening period to provide fresh tumor tissue for PD-L1 and PIK3CA mutation testing; if a biopsy is not feasible, archived tumor tissue samples (formalin-fixed, paraffin-embedded (FFPE) blocks or unstained FFPE slides) may be provided for PD-L1 testing. All testing will be performed at a central laboratory. If the provided tumor tissue sample is deemed unsuitable by the central laboratory for evaluating PD-L1 expression and/or PIK3CA mutation status, the subject cannot be enrolled.
Must have at least one measurable lesion as per RECIST v1.1 criteria. Previously irradiated lesions with confirmed progression on imaging may be considered as target lesions.
ECOG performance status of 0 or 1.
Able to swallow tablets normally.
Life expectancy of ≥3 months.
Exclusion Criteria:
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| Investigator's Choice of Chemotherapy | Drug | Randomization for these two strata will be closed upon reaching the total enrollment of 310 subjects who are immunotherapy-naïve or have tumors with PIK3CA wild-type status confirmed by the central laboratory. |
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| through study completion, an average of 3 years |
| Efficacy including DCR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria. | through study completion, an average of 1 year |
| Efficacy including DoR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria. | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
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