Cervical CancerPhase 3NCT06459687
Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
A Phase 3 study testing Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab in people with Cervical Cancer, run by Lee's Pharmaceutical Limited at 5 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. 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?
- Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 5 sitesChina
- Study dates
- 28 Nov 2024to 1 Sep 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. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.
- 2. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female.
- 3. ECOG Physical fitness score was 0 or 1.
- 4. Life expectancy ≥ 3 months.
- 5. Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy.
- 6. Have at least one measurable tumor lesion examined by CT or MRI according to RECIST v1.1 criteria;
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- 7. All subjects must provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded [FFPE] tissue wax blocks or at least 5 unstained tumor tissue section samples, preferably newly obtained tumor tissue samples) within the previous 5 years of randomization.
- 8. Laboratory examination results during the screening period indicate that the subject has good organ function.
- 9. Effective contraception should be used by fertile female subjects from the signing of informed consent until 180 days after the last administration of the study drug.
Who cannot join
- 1. Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
- 2. Prior anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or targeting immune costimulators (e.g. antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and any treatment targeting the immune mechanism of tumor.
- 3. Active or potentially recurring autoimmune disease.
- 4. Patients with other active malignant tumors within 3 years prior to randomization.
- 5. Participants who had participated in other clinical studies and used other clinical trial drugs within 4 weeks before randomization.
- 6. Major surgery, open biopsy or significant trauma within 4 weeks before randomization; Or an expected major surgical treatment during the study.
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- 7. Anti-tumor therapy within 4 weeks before randomization.
- 8. Severe infection occurring within 4 weeks prior to randomization.
- 9. Vaccination within 4 weeks prior to randomization.
- 10. Received immune-modulating drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization.
- 11. Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to randomization.
- 12. Subjects requiring systemic treatment with corticosteroids (> 10 mg/ day of prednisone or equivalent doses of corticosteroids) or other immunosuppressive drugs within 2 weeks prior to randomization.
- 13. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as determined by the investigator.
- 14. Central nervous system metastatic or cancerous meningitis.
- 15. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage (more frequently than monthly).
- 16. Known primary or secondary immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
- 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- 18. Known active tuberculosis; Known active treponema pallidum infection.
- 19. known history of severe hypersensitivity to other monoclonal antibodies.
- 20. Known contraindications to cisplatin/carboplatin, paclitaxel, or allergies to any components.
- 21. Previous and/or current presence of interstitial lung disease, pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function, etc., that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- 22. Subjects with active viral hepatitis B, inactive or asymptomatic carriers of hepatitis B virus (HBV) (positive for hepatitis B surface antigen [HBsAg]) with HBV DNA > 500 IU/mL or > 2500 copies/mL), and subjects with active viral hepatitis C.
- 23. Active or documented inflammatory bowel disease.
- 24. Any of the following cardiovascular diseases: a) myocardial infarction, unstable angina pectoris, pulmonary embolism, aortic dissection, deep vein thrombosis, and any arterial thromboembolism event occurred within 6 months before randomization; b) New York Heart Association (NYHA) heart function grade ≥ II heart failure; c) There is a serious arrhythmia that requires drug intervention; Patients with asymptomatic atrial fibrillation with stable ventricular rate were admitted; d)Left ventricular ejection fraction (LVEF) < 50%.
- 25. NCI CTCAE v5.0 ≥ 2 grade peripheral neuropathy.
- 26. Not recovered from toxicity of previous antitumor therapy.
- 27. Pregnant or lactating women.
- 28. Any condition (such as another serious illness or psychiatric disorder) that the investigator believes may result in a risk for acceptance of the study drug or that would interfere with the evaluation of the study drug or with the safety of the subjects or the interpretation of the study results.
- 29. Known contraindications to bevacizumab or allergies to any of its components, or the presence of any medical conditions that could affect the safety of bevacizumab administration.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Hong Fang, Dr., 010-87788787, cancergcp@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Lin Liao, Dr., 0731-88651900, liaolin@hnca.org.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Dan Hong, Dr., 0571-88122261, hongdan@zjcc.org.cn
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Xinchen Wang, Dr., 0551-65329163, ahszlyygcp@163.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wanting Ji, Dr., 027-85726685, ahszlyygcp@163.com
About this study
Official title: Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
- Conditions
- Cervical Cancer
- Being tested
- Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab, Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab
- 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.
Socazolimab+cisplatin/carboplatin+paclitaxel+BevacizumabDrug
6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.
Followed with Socazolimab (5 mg/kg), Q3w.
Placebo+cisplatin/carboplatin+paclitaxel+BevacizumabDrug
6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.
Followed with placebo (5 mg/kg), Q3w.
| Study group | Role | What they receive |
|---|---|---|
| Socazolimab+Chemotherapy±Bevacizumab | Experimental | 6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.
Followed with Socazolimab (5 mg/kg), Q3w. Receives: Drug: Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab |
| Placebo+Chemotherapy±Bevacizumab | Placebo comparator | 6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.
Followed with placebo (5 mg/kg), Q3w. Receives: Drug: Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From date of randomization to date of death from any cause, assessed up to 100 months.
Secondary outcomes (17)
PFS (assessed by BICR, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by BICR, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by BICR, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by BICR, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by BICR, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
PFS (assessed by investigators, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by investigators, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by investigators, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by investigators, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by investigators, based on RECIST v1.1)
Measured: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
Safety: adverse events, clinical abnormalties
Measured: from written informed concent to 90 days after last dose
Tmax
Measured: from 30min before first dose to 30 days after last dose
Cmax
Measured: from 30min before first dose to 30 days after last dose
T1/2
Measured: from 30min before first dose to 30 days after last dose
Immunogenicity
ADA, NAb
Measured: from 30min before first dose to 30 days after last dose
Health-related quality of life (HRQoL)
using EORTC QLQ-C30 Questionnaire
Measured: from screening to end of treatment visit, up to 100 months
PD-L1 status
Measured: up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start28 Nov 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459687
- Sponsor's protocol ID
- ZKAB001-LEES-2024-01
- Status last verified
- May 2025
- First submitted
- 3 Jun 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study
- ClinicalTrials.gov ID
- NCT06459687
- Acronym / sponsor ID
- ZKAB001-LEES-2024-01
- Conditions
- Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Jun 2024 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Socazolimab+Chemotherapy±Bevacizumab | Experimental | Drug: Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with Socazolimab (5 mg/kg), Q3w. |
| Placebo+Chemotherapy±Bevacizumab | Placebo comparator | Drug: Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with placebo (5 mg/kg), Q3w. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.
- 2. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female.
- 3. ECOG Physical fitness score was 0 or 1.
- 4. Life expectancy ≥ 3 months.
- 5. Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy.
Key exclusion criteria (29 listed)
- 1. Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
- 2. Prior anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or targeting immune costimulators (e.g. antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and any treatment targeting the immune mechanism of tumor.
- 3. Active or potentially recurring autoimmune disease.
- 4. Patients with other active malignant tumors within 3 years prior to randomization.
- 5. Participants who had participated in other clinical studies and used other clinical trial drugs within 4 weeks before randomization.
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 |
|---|---|---|
| Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with Socazolimab (5 mg/kg), Q3w. | Drug | Socazolimab+Chemotherapy±Bevacizumab |
| Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with placebo (5 mg/kg), Q3w. | Drug | Placebo+Chemotherapy±Bevacizumab |
Primary outcome
Overall survival
Time frame: From date of randomization to date of death from any cause, assessed up to 100 months.
17 secondary outcomes
PFS (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
PFS (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
Safety: adverse events, clinical abnormalties
Time frame: from written informed concent to 90 days after last dose
Tmax
Time frame: from 30min before first dose to 30 days after last dose
Cmax
Time frame: from 30min before first dose to 30 days after last dose
T1/2
Time frame: from 30min before first dose to 30 days after last dose
Immunogenicity
Time frame: from 30min before first dose to 30 days after last dose
Health-related quality of life (HRQoL)
Time frame: from screening to end of treatment visit, up to 100 months
PD-L1 status
Time frame: up to 100 months
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 14 May 2025.
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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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab in people with Cervical Cancer, run by Lee's Pharmaceutical Limited at 5 sites in China.
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 29 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of randomization to date of death from any cause, assessed up to 100 months.). 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 14 May 2025.