Head and Neck Squamous Cell CarcinomaPhase 2NCT06194656
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing HER3 Monoclonal antibodies-Dose A, HER3 Monoclonal antibodies-Dose B and HER3 Monoclonal antibodies-Dose C in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Institute Of Biological Products at 2 sites in China.
Trial summary
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- HER3 Monoclonal antibodies-Dose A, HER3 Monoclonal antibodies-Dose B and HER3 Monoclonal antibodies-Dose C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesChina
- Study dates
- 27 Sep 2024to 30 Jul 2026
- Phase
- Phase 2
- 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 subjects voluntarily participated in the study and signed the informed consent.
- Male and female aged between 18 and 75 years old, regardless of gender.
- Patients with recurrent/metastatic advanced HNSCC who have been diagnosed by histology or cytology, progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1 and platinum, and have no indication of radical local treatment. Subjects should not receive more than 2 lines of treatment in the past.
- During the screening period, subjects must provide tumor tissues and blood samples for biomarker detection. If the subject does not have an archived tumor tissue sample, he or she will undergo a fresh tumor biopsy during the screening period to obtain the corresponding tumor sample. If the subject can't provide archived or fresh tumor tissue samples, but can provide the previous test reports of qualified institutions, including all biomarker indicators specified in this scheme, they can be screened after communicating with the sponsor.
- There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 standard). Tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not measurable lesions unless the lesion has definite progression.
- The ECOG physical fitness score is 0-1.
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- The laboratory test results meet the requirements.
- The expected survival time is ≥ 3 months.
- In fertile female subjects, the blood pregnancy test must be negative within 7 days before the first medication. Subjects of reproductive age (including male subjects) had no family planning during the trial period and within 6 months after the last administration and voluntarily took effective contraceptive measures.
Who cannot join
- The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses, nasopharynx and salivary gland.
- The participant has received any HER3 targeting or EGFR targeting therapy in the past.
- Active central nervous system metastasis and/or meningeal metastasis.
- Previous allergy to human normal immunoglobulin or antibody preparation or other serious infusion reaction; Severe hypersensitivity disease, allergic constitution.
- In the past 5 years, the subjects had suffered from malignant tumors other than those treated in this study (except cured thyroid cancer, skin basal cell carcinoma and cervical carcinoma in situ).
- People infected with active human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B vrius (HBV), syphilis or active tuberculosis, and asymptomatic chronic hepatitis B or hepatitis C carriers may be excluded.
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- The subjects have not recovered from the toxicity of previous anti-tumor therapy to grade ≤ 1 or baseline level (except participants with hair loss, neuropathy of grade ≤ 2 or stabilized thyroid function's decline by hormon replacement therapy).
- Subjects are currently participating in and receiving research treatment or have been treated with other research drugs or medical devices within 4 weeks before the first use of research drugs.
- Patients who plan to receive any other anti-tumor treatment during the trial should be excluded.
- Major surgery, radiotherapy (except palliative radiotherapy for targeted bone metastasis), or treatment such as unhealed surgical wound, ulcer or fracture within 4 weeks before the first administration; Received Chinese patent medicines or Chinese herbal medicines with anti-tumor indications within 2 weeks before the first administration; Chemotherapy was received within 3 weeks before the first administration, and anti-tumor treatments such as biotherapy, endocrine therapy, targeted therapy and immunotherapy were received within 4 weeks
- Those who have been vaccinated live within 30 days before the first administration.
- Active infections requiring systemic treatment, such as pneumonia, bacteremia, septicemia, etc.
- A history of pulmonary interstitial disease, pulmonary interstitial fibrosis or drug-induced interstitial pneumonia or other clinically serious lung diseases (CTCAE 5.0 grade III-IV).
- Pulmonary thromboembolism, arterial thrombosis and deep vein thrombosis formation (DVT) occurred within 6 months before screening, except for infusion set-related thrombosis.
- Have a history or evidence of cardiovascular (CV) risk.
- During the screening period, 12-lead electrocardiogram (ECG) measurement was performed in the research center (the average value of QTcF that needs to be measured repeatedly for 3 times), and the QT interval (QTcF) corrected by Fridericia method was > 450 milliseconds (male) or (QTcF) > 470 milliseconds (female); LVEF of cardiac ultrasound was less than 50%.
- Therapeutic surgery was performed within 28 days before the first administration, or major surgery was expected during the study period (except diagnosis, biopsy and drainage).
- People with mental disorders or poor compliance.
- Pregnant or lactating women.
- According to the researcher's judgment, there are accompanying diseases (such as severe hypertension, diabetes, thyroid diseases, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.
- Suffering from diseases requiring long-term treatment with high doses (defined as 30mg/d hydrocortisone or equivalent doses of other hormonal drugs) of hormones or immunosuppressive drugs.
- After active treatment, uncontrollable pleural and abdominal cavity or other lacunar effusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Ye Guo, Doctor
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Ye Guo, 021-38804518-28329, pattrickguo@gmail.com
Ye Guo
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent/Metastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
Read the detailed description
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up. The participants in both study parts are the same, both of whom were patients with recurrent/metastatic advanced HNSCC (non nasopharyngeal carcinoma).
- a is an open-label study. Part one, 12 subjects were randomly assigned 1:1 to two groups and treated with SIBP-03 dose A or dose B every 3 weeks (Q3W) combined with cetuximab every week (QW). Part two, 3 subjects were treated with SIBP-03 dose C Q3W combined with cetuximab QW. If 1/3 subjects (1 case) have DLT, 3 more subjects need to continue to observe the safety and tolerance; If DLT occurs in 3 cases or ≥ 2 cases in 6 cases, the sponsor and the researcher will discuss and decide whether to terminate this part of the study or change the dose. 12 subjects were added at most.
- b is a randomized, double-blind study. Including an experimental group (RP2D) and a placebo control group. The qualified subjects in this stage will be randomly assigned according to the ratio of 2: 1, including 38 cases in the experimental group and 19 cases in the control group, with a total of 57 subjects.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- HER3 Monoclonal antibodies-Dose A, HER3 Monoclonal antibodies-Dose B, HER3 Monoclonal antibodies-Dose C, HER3 Monoclonal antibodies-Dose D, Placebo
- Keywords
- Head and neck squamous cell carcinoma, safety, tolerability, pharmacokinetics, efficacy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER3 Monoclonal antibodies-Dose ADrug
Dose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
HER3 Monoclonal antibodies-Dose BDrug
Dose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
HER3 Monoclonal antibodies-Dose CDrug
Dose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
HER3 Monoclonal antibodies-Dose DOther
The optimal recommended dosage (RP2D) of SIBP-03intravenous, infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min).
PlaceboOther
SIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks, 21 days as a cycle.
Cetuximab injectionCombination product
Medications used for combination therapy, intravenous infusion (IV). Administer once a week.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Experimental group in Ⅱa (part one). It will be the dose A of SIBP-03. It will determine whether the dose A is the optimal recommended dosage (RP2D) based on actual study results. Receives: Drug: HER3 Monoclonal antibodies-Dose A; Combination Product: Cetuximab injection |
| Group B | Experimental | Experimental group in Ⅱa (part one). It will be the dose B of SIBP-03. It will determine whether the dose B is the RP2D based on actual study results. Receives: Drug: HER3 Monoclonal antibodies-Dose B; Combination Product: Cetuximab injection |
| Group C | Experimental | Experimental group in Ⅱa (part two). It will be the dose C of SIBP-03. It will determine whether the dose C is the RP2D based on actual study results. Receives: Drug: HER3 Monoclonal antibodies-Dose C; Combination Product: Cetuximab injection |
| Group D | Experimental | Experimental group in Ⅱb. It will be the RP2D of SIBP-03. Receives: Other: HER3 Monoclonal antibodies-Dose D; Combination Product: Cetuximab injection |
| Group E | Placebo comparator | Placebo of SIBP-03 (SIBP-03 solvent without HER3 antibody), and the dose will be the same with group D. Receives: Other: Placebo; Combination Product: Cetuximab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of any adverse events (AE)
All subjects after receiving the investigational drug were observed during the trial for any AE that occurred during the clinical study.AE were manifested as symptoms, signs, diseases, or abnormal laboratory tests, but may not necessarily have a causal relationship with the investigational drug.
Measured: 30 days after the last dose
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the subject during the study period.
Measured: 30 days after the last dose
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: 30 days after the last dose
Tmax(Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the subject plasma concentration curve after administration.
Measured: 30 days after the last dose
T ½(Terminal elimination half-life)
It reflects how quickly the drug is eliminated from the body.
Measured: 30 days after the last dose
CL(Clearance Rate)
Apparent volume of drug distribution removed from the body per unit time.
Measured: 30 days after the last dose
Difference of ORR
Differences in ORR between SIBP-03 and placebo evaluated by the Independent Evaluation Committee (IRC) according to RECIST 1.1. Only applicable to part two.
Measured: The 1 day the test results reported after the last dose
Secondary outcomes (5)
ORR (Objective Response Rate)
The proportion of subjects whose tumor volume shrinks to a predetermined value and maintains the minimum time limit, and is the sum of complete and partial responses.
Measured: The 1 day the test results reported after the last dose
DCR (Disease control rate)
In clinical trials, the percentage of subjects with advanced or metastatic cancer who responded fully to cancer treatment, partially responded, and had stable disease.
Measured: The 1 day the test results reported after the last dose
PFS (Progression-free survival)
The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).
Measured: The 1 day the test results reported after the last dose
ADA (Anti-drug Antibody)
The incidence of anti-drug antibody.
Measured: The 1 day the test results reported after the last dose
NAb (Neutralizing Antibody)
The incidence of neutralizing antibody.
Measured: The 1 day the test results reported after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start27 Sep 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ⅱa is an open-label study and Ⅱb is a randomized, double-blind study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Doctor, Principal investigator, Shanghai Oriental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194656
- Sponsor's protocol ID
- SIBP-03-02
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of SIBP-03 Injection Combined With Cetuximab in Patients With Recurrent/Metastatic Advanced Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma)
- ClinicalTrials.gov ID
- NCT06194656
- Acronym / sponsor ID
- SIBP-03-02
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and neck squamous cell carcinoma, safety, tolerability, pharmacokinetics, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Jan 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.
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
Detailed description
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up. The participants in both study parts are the same, both of whom were patients with recurrent/metastatic advanced HNSCC (non nasopharyngeal carcinoma).
- a is an open-label study. Part one, 12 subjects were randomly assigned 1:1 to two groups and treated with SIBP-03 dose A or dose B every 3 weeks (Q3W) combined with cetuximab every week (QW). Part two, 3 subjects were treated with SIBP-03 dose C Q3W combined with cetuximab QW. If 1/3 subjects (1 case) have DLT, 3 more subjects need to continue to observe the safety and tolerance; If DLT occurs in 3 cases or ≥ 2 cases in 6 cases, the sponsor and the researcher will discuss and decide whether to terminate this part of the study or change the dose. 12 subjects were added at most.
- b is a randomized, double-blind study. Including an experimental group (RP2D) and a placebo control group. The qualified subjects in this stage will be randomly assigned according to the ratio of 2: 1, including 38 cases in the experimental group and 19 cases in the control group, with a total of 57 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Ⅱa is an open-label study and Ⅱb is a randomized, double-blind study.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HER3 Monoclonal antibodies-Dose A, Combination Product: Cetuximab injectionExperimental group in Ⅱa (part one). It will be the dose A of SIBP-03. It will determine whether the dose A is the optimal recommended dosage (RP2D) based on actual study results. |
| Group B | Experimental | Drug: HER3 Monoclonal antibodies-Dose B, Combination Product: Cetuximab injectionExperimental group in Ⅱa (part one). It will be the dose B of SIBP-03. It will determine whether the dose B is the RP2D based on actual study results. |
| Group C | Experimental | Drug: HER3 Monoclonal antibodies-Dose C, Combination Product: Cetuximab injectionExperimental group in Ⅱa (part two). It will be the dose C of SIBP-03. It will determine whether the dose C is the RP2D based on actual study results. |
| Group D | Experimental | Other: HER3 Monoclonal antibodies-Dose D, Combination Product: Cetuximab injectionExperimental group in Ⅱb. It will be the RP2D of SIBP-03. |
| Group E | Placebo comparator | Other: Placebo, Combination Product: Cetuximab injectionPlacebo of SIBP-03 (SIBP-03 solvent without HER3 antibody), and the dose will be the same with group D. |
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 subjects voluntarily participated in the study and signed the informed consent.
- Male and female aged between 18 and 75 years old, regardless of gender.
- Patients with recurrent/metastatic advanced HNSCC who have been diagnosed by histology or cytology, progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1 and platinum, and have no indication of radical local treatment. Subjects should not receive more than 2 lines of treatment in the past.
- During the screening period, subjects must provide tumor tissues and blood samples for biomarker detection. If the subject does not have an archived tumor tissue sample, he or she will undergo a fresh tumor biopsy during the screening period to obtain the corresponding tumor sample. If the subject can't provide archived or fresh tumor tissue samples, but can provide the previous test reports of qualified institutions, including all biomarker indicators specified in this scheme, they can be screened after communicating with the sponsor.
- There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 standard). Tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not measurable lesions unless the lesion has definite progression.
Key exclusion criteria (22 listed)
- The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses, nasopharynx and salivary gland.
- The participant has received any HER3 targeting or EGFR targeting therapy in the past.
- Active central nervous system metastasis and/or meningeal metastasis.
- Previous allergy to human normal immunoglobulin or antibody preparation or other serious infusion reaction; Severe hypersensitivity disease, allergic constitution.
- In the past 5 years, the subjects had suffered from malignant tumors other than those treated in this study (except cured thyroid cancer, skin basal cell carcinoma and cervical carcinoma in situ).
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 |
|---|---|---|
| HER3 Monoclonal antibodies-Dose ADose A, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min). | Drug | Group A |
| HER3 Monoclonal antibodies-Dose BDose B, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min). | Drug | Group B |
| HER3 Monoclonal antibodies-Dose CDose C, intravenous infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min). | Drug | Group C |
| HER3 Monoclonal antibodies-Dose DThe optimal recommended dosage (RP2D) of SIBP-03intravenous, infusion (IV), once every three weeks, 21 days as a cycle. The infusion time is 90 min (± 5 min). | Other | Group D |
| PlaceboSIBP-03 solvent without HER3 antibody, intravenous infusion (IV), once every one weeks, 21 days as a cycle. | Other | Group E |
| Cetuximab injectionMedications used for combination therapy, intravenous infusion (IV). Administer once a week. | Combination product | Group A, Group B, Group C, Group D, Group E |
Primary outcome
The occurrence of any adverse events (AE)
Time frame: 30 days after the last dose
All subjects after receiving the investigational drug were observed during the trial for any AE that occurred during the clinical study.AE were manifested as symptoms, signs, diseases, or abnormal laboratory tests, but may not necessarily have a causal relationship with the investigational drug.
SAE (Serious Adverse Events)
Time frame: 30 days after the last dose
That is serious adverse events, any serious adverse events that occurred to the subject during the study period.
Cmax (Peak Plasma Concentration)
Time frame: 30 days after the last dose
It shows the highest plasma concentration of a drug that can be achieved after administration.
Tmax(Peak Time)
Time frame: 30 days after the last dose
That is peak time of drug action, it shows the time required to reach the maximum concentration on the subject plasma concentration curve after administration.
T ½(Terminal elimination half-life)
Time frame: 30 days after the last dose
It reflects how quickly the drug is eliminated from the body.
CL(Clearance Rate)
Time frame: 30 days after the last dose
Apparent volume of drug distribution removed from the body per unit time.
Difference of ORR
Time frame: The 1 day the test results reported after the last dose
Differences in ORR between SIBP-03 and placebo evaluated by the Independent Evaluation Committee (IRC) according to RECIST 1.1. Only applicable to part two.
5 secondary outcomes
ORR (Objective Response Rate)
Time frame: The 1 day the test results reported after the last dose
DCR (Disease control rate)
Time frame: The 1 day the test results reported after the last dose
PFS (Progression-free survival)
Time frame: The 1 day the test results reported after the last dose
ADA (Anti-drug Antibody)
Time frame: The 1 day the test results reported after the last dose
NAb (Neutralizing Antibody)
Time frame: The 1 day the test results reported after the last dose
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 16 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Ye Guo, Doctor principal investigator
Shanghai Oriental Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HER3 Monoclonal antibodies-Dose A, HER3 Monoclonal antibodies-Dose B and HER3 Monoclonal antibodies-Dose C in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Institute Of Biological Products at 2 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 22 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Dandan Chen, Master (86-021-62800991, ddchen.sh@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of any adverse events (AE) (time frame: 30 days after the last dose). The study lists 7 primary outcomes in all. 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 16 Jan 2026.