Cervical Cancer MetastaticPhase 3NCT07392060
A Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based Treatment
A Phase 3 study testing WX390 1.1mg + Toripalimab 240mg and Investigator's Choice of Chemotherapy in people with Cervical Cancer Metastatic, run by Shanghai Jiatan Pharmatech Co., Ltd.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Cancer Metastatic
- What is being tested?
- WX390 1.1mg + Toripalimab 240mg and Investigator's Choice of Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 30 Jun 2030
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- ECOG performance status of 0 or 1.
- Able to swallow tablets normally.
- Life expectancy of ≥3 months.
Who cannot join
- Previous treatment with any PI3K, AKT, or mTOR inhibitor, or prior treatment with toripalimab.
- Patients with type 1 or type 2 diabetes mellitus.
- History of interstitial lung disease, drug-induced pneumonitis, pulmonary fibrosis, pneumoconiosis, or radiation pneumonitis (patients with only radiographic evidence of radiation pneumonitis and not requiring corticosteroid therapy may be enrolled). Patients with active pneumonia during screening, severely impaired lung function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Radiographic evidence of tumor invasion into the bladder or rectum, deemed by the investigator to pose a risk of perforation; or a known history of female reproductive tract fistula (e.g., vesicovaginal fistula, urethrovaginal fistula, cervicovesical fistula, etc.). Patients may be enrolled if the perforation or fistula has been treated with diversion surgery, resection, or repair, and the condition is considered resolved or controlled by the investigator.
- Currently active bleeding, intra-abdominal abscess, or intestinal obstruction requiring clinical intervention.
- CT/MRI or other imaging shows tumor invasion or encasement of major blood vessels, indicating a high risk of bleeding.
Show all 11Show fewer
- Current clinically significant hydronephrosis. Patients may be enrolled if hydronephrosis is relieved by nephrostomy or ureteral stent placement.
- Patients with refractory nausea and vomiting, dysphagia, gastrointestinal disorders affecting drug absorption (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome), or other malabsorption conditions.
- History of severe allergy, hypersensitivity, or other anaphylactic reactions to the investigational product or any of its excipients.
- Administration of a live vaccine within 4 weeks prior to randomization or planned administration during the study.
- Patients with active autoimmune disease, history of bone marrow or solid organ transplantation, suicidal tendency, alcohol or drug dependence, clear history of neurological or psychiatric disorders, or other conditions that, in the investigator's assessment, may contraindicate the use of the investigational product, compromise the interpretation of study results, or result in forced discontinuation from the study.
About this study
Official title: A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based Treatment
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).
- Conditions
- Cervical Cancer Metastatic
- Being tested
- WX390 1.1mg + Toripalimab 240mg, Investigator's Choice of Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX390 1.1mg + Toripalimab 240mgDrug
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 ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: WX390 1.1mg + Toripalimab 240mg |
| Investigator's Choice of Chemotherapy | Active comparator | Not described Receives: Drug: Investigator's Choice of Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in cervical cancer patients who have failed at least one prior line of platinum-based therapy
Measured: through study completion, an average of 3 years
Secondary outcomes (4)
Efficacy including ORR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392060
- Sponsor's protocol ID
- JYP0390M301
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based Treatment
- ClinicalTrials.gov ID
- NCT07392060
- Acronym / sponsor ID
- JYP0390M301
- Conditions
- Cervical Cancer Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WX390 1.1mg + Toripalimab 240mg | Experimental | Drug: WX390 1.1mg + Toripalimab 240mgParticipants 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 | Drug: Investigator's Choice of Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- Previous treatment with any PI3K, AKT, or mTOR inhibitor, or prior treatment with toripalimab.
- Patients with type 1 or type 2 diabetes mellitus.
- History of interstitial lung disease, drug-induced pneumonitis, pulmonary fibrosis, pneumoconiosis, or radiation pneumonitis (patients with only radiographic evidence of radiation pneumonitis and not requiring corticosteroid therapy may be enrolled). Patients with active pneumonia during screening, severely impaired lung function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Radiographic evidence of tumor invasion into the bladder or rectum, deemed by the investigator to pose a risk of perforation; or a known history of female reproductive tract fistula (e.g., vesicovaginal fistula, urethrovaginal fistula, cervicovesical fistula, etc.). Patients may be enrolled if the perforation or fistula has been treated with diversion surgery, resection, or repair, and the condition is considered resolved or controlled by the investigator.
- Currently active bleeding, intra-abdominal abscess, or intestinal obstruction requiring clinical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WX390 1.1mg + Toripalimab 240mgParticipants will receive WX390 continuous oral dosing (1.1 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). | Drug | WX390 1.1mg + Toripalimab 240mg |
| Investigator's Choice of ChemotherapyRandomization 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. | Drug | Investigator's Choice of Chemotherapy |
Primary outcome
Overall survival in cervical cancer patients who have failed at least one prior line of platinum-based therapy
Time frame: through study completion, an average of 3 years
4 secondary outcomes
Efficacy including ORR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Related trials for Cervical Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WX390 1.1mg + Toripalimab 240mg and Investigator's Choice of Chemotherapy in people with Cervical Cancer Metastatic, run by Shanghai Jiatan Pharmatech 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 9 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 6 Feb 2026. 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 in cervical cancer patients who have failed at least one prior line of platinum-based therapy (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.