Advanced Breast CancerPhase 2NCT06649331
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
A Phase 2 study testing SHR-A1811, SHR-A1921 and SHR-A2009 in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC)
- What is being tested?
- SHR-A1811, SHR-A1921 and SHR-A2009
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
- Previously received ADCs;
- The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2. Participants with any hormone receptor (HR) status will be allowed on study.
- Prior endocrine therapy: Participants with HR-positive breast cancer must have received prior CDK4/6 inhibitor;
- Participants must have measurable disease per RECIST 1.1.
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- The functions of the main organs are basically normal and meet the following conditions:
- Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10^9 / L; PLT acuity 75 x 10^9 / L; II. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); III. LVEF≥50%
- They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity; Participants may have discontinued all CDK4/6 inhibitor at least 14 days prior to study treatment initiation. Prior endocrine therapy does not require washout.
- ECOG score ≤2, and life expectancy ≥3 months;
- Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
- Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
- Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
- A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
- Presence of the third space effusion (such as massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods;
- Participants with who had used immunosuppressive agents or systemic corticosteroids within 2 weeks before the first dose (dose> 10mg/day prednisone or other corticosteroids at the physiological dose of the drug), excluding nasal spray or inhaled corticosteroids;
- Presence of any active autoimmune disease or a history of autoimmune disease with potential relapse;
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- Known human immunodeficiency virus (HIV) infection that is not well controlled;
- Known active hepatitis B (HBV DNA≥2000 IU/mL or 104 copies/mL) and hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower detection limit of the assay);
- Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
- Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
- Pregnant or lactating patients;
- Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications;
- Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results
- Deemed by the investigator to be ineligible for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, M.D, 86-21-64175590, zhimingshao@yahoo.com
Xiyu Liu, M.D.
About this study
Official title: Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer：A Prospective, Open-label, Phase 2 Trial
This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.
Read the detailed description
This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously received ADCs.
The primary endpoint is objective response rate (ORR). This trial aims to learn whether ADC rechallenge works in treating in ADC-treated metastatic breast cancer and identify which ADC works better for subsets on the basis of molecular characteristics and ADC treatment history of their disease with high ORR. Study drugs involved in this study including but not limited to: SHR-A1811 (HER2 ADC), SHR-A1921 (TROP2 ADC), SHR-A2009 (HER3 ADC) and SHR-A2102 (Nectin-4 ADC).
This platform trial is adaptive design. Novel ADC regimens with sufficiently high activities that show a high Bayesian predictive probability will graduate from the trial with their corresponding biomarker signature(s). ADCs will be dropped if they show a low probability of improved efficacy with any biomarker signature. New ADCs will enter as those that have undergone testing complete their evaluation.
Based on the existing four ADC treatment cohorts on this platform, a maximum of 120 subjects were planned to be enrolled in each ADC treatment cohort. According to the previous ADC treatment history and target, the subjects were randomly assigned to each cohort. On the basis of previous clinical data at our center, we limited the enrollment of a minimum of 10 participants per cohort to avoid underrepresentation of any cohort. During the course of the study, ORR will be evaluated periodically for every additional 10 results according to the Bayesian monitoring method. Graduation (successful validation) or elimination (failed validation) of ADC rechallenge treatment will be considered according to the posterior probability of an ADC cohort and the data of primary efficacy endpoint, secondary efficacy endpoints and safety endpoints. Additional targeted regimens may be added to the platform regimen as feasible as assessed by the investigators, and the protocol will be modified accordingly at that time.
The efficacy was evaluated by CT or MRI every 6 weeks (±1 week) according to RECIST 1.1. Subjects with CR or PR were required to have radiologic response confirmation at least 4 weeks. Tumor assessments were performed every 9 weeks (±1 week) after 36 weeks of treatment until disease progression, initiation of new antineoplastic therapy, withdrawal of consent, loss to follow-up, death, or the end of the study, whichever occurred first.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative Breast Cancer, Breast Cancer
- Being tested
- SHR-A1811, SHR-A1921, SHR-A2009, SHR-A2102, Famitinib
- Keywords
- platform trial, adaptive design, antibody-conjugated drugs (ADCs), Bayesian predictive probability
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A1921Drug
A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A2009Drug
A HER3-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A2102Drug
A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
FamitinibDrug
A VEGFR inhibitor administered orally per the protocol.
Fat Module Formula for Special Medical PurposesDietary supplement
This nutritional formulation is composed primarily of medium-chain triglycerides (MCT), which are metabolized by the liver to induce nutritional ketosis, thereby significantly elevating circulating levels of beta-hydroxybutyrate (BHB).
Trastuzumab (or biosimilar)Drug
An anti-HER2 antibody, via intravenous (into the vein) infusion or subcutaneous per protocol.
9MW2821Drug
A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
Disitamab Vedotin (RC48)Drug
A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
Treatment of physician's choice (TPC)Drug
Treatment of physician's choice (TPC), such as nab-paclitaxel, carboplatin, gemcitabine, capecitabine, vinorelbine, eribulin, etc., with specific dosages and administration methods determined at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | SHR-A1811 (HER2 ADC) Receives: Drug: SHR-A1811 |
| B | Experimental | SHR-A1921 (TROP2 ADC) Receives: Drug: SHR-A1921 |
| C | Experimental | SHR-A2009 (HER3 ADC) Receives: Drug: SHR-A2009 |
| D | Experimental | SHR-A2102 (Nectin4 ADC) Receives: Drug: SHR-A2102 |
| E | Experimental | SHR-A1811 (HER2 ADC) and Famitinib (VEGFR inhibitor) Receives: Drug: SHR-A1811; Drug: Famitinib |
| F | Experimental | SHR-A1811 (HER2 ADC) and Fat Module Formula for Special Medical Purposes (for Medium-Chain Triglyceride Supplementation) Receives: Drug: SHR-A1811; Dietary Supplement: Fat Module Formula for Special Medical Purposes |
| G | Experimental | 9MW2821 (Nectin4 ADC) Receives: Drug: 9MW2821 |
| H | Experimental | 9MW2821 (Nectin4 ADC) + trastuzumab Receives: Drug: Trastuzumab (or biosimilar); Drug: 9MW2821 |
| I | Experimental | Disitamab Vedotin (RC48) Receives: Drug: Disitamab Vedotin (RC48) |
| J | Experimental | Treatment of physician's choice (TPC) Receives: Drug: Treatment of physician's choice (TPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined per protocol.
Measured: The observation period related to this endpoint is up to 36 months.
Secondary outcomes (6)
Progression Free Survival (PFS)
PFS based on Kaplan-Meier methodology will be defined as the time from randomization until the identification of disease progression or death, whichever occurs first. Subjects without disease progression or death at the time of analysis will be censored at the date of last disease evaluation.
Measured: The observation period related to this endpoint is up to 36 months.
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of participants with CR, PR and stable disease (SD) for ≥ 4 weeks as the best overall response.
Measured: The observation period related to this endpoint is up to 36 months.
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is defined as the proportion of participants with CR, PR and stable disease (SD) for ≥ 24 weeks as the best overall response.
Measured: The observation period related to this endpoint is up to 36 months.
Duration of Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause). Participants without reported events are censored at the last disease evaluation.
Measured: The observation period related to this endpoint is up to 36 months.
Overall Survival (OS)
Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
Measured: The observation period related to this endpoint is up to 5 years.
Treatment-Related Toxicity Rate
The percentage of participants who experienced any grade treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Measured: The observation period related to this endpoint is up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start21 Oct 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649331
- Sponsor's protocol ID
- SCHBCC-N076
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer：A Prospective, Open-label, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT06649331
- Acronym / sponsor ID
- SCHBCC-N076
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative Breast Cancer, Breast Cancer
- Keywords
- platform trial, adaptive design, antibody-conjugated drugs (ADCs), Bayesian predictive probability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Oct 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 is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.
Detailed description
This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously received ADCs.
The primary endpoint is objective response rate (ORR). This trial aims to learn whether ADC rechallenge works in treating in ADC-treated metastatic breast cancer and identify which ADC works better for subsets on the basis of molecular characteristics and ADC treatment history of their disease with high ORR. Study drugs involved in this study including but not limited to: SHR-A1811 (HER2 ADC), SHR-A1921 (TROP2 ADC), SHR-A2009 (HER3 ADC) and SHR-A2102 (Nectin-4 ADC).
This platform trial is adaptive design. Novel ADC regimens with sufficiently high activities that show a high Bayesian predictive probability will graduate from the trial with their corresponding biomarker signature(s). ADCs will be dropped if they show a low probability of improved efficacy with any biomarker signature. New ADCs will enter as those that have undergone testing complete their evaluation.
Based on the existing four ADC treatment cohorts on this platform, a maximum of 120 subjects were planned to be enrolled in each ADC treatment cohort. According to the previous ADC treatment history and target, the subjects were randomly assigned to each cohort. On the basis of previous clinical data at our center, we limited the enrollment of a minimum of 10 participants per cohort to avoid underrepresentation of any cohort. During the course of the study, ORR will be evaluated periodically for every additional 10 results according to the Bayesian monitoring method. Graduation (successful validation) or elimination (failed validation) of ADC rechallenge treatment will be considered according to the posterior probability of an ADC cohort and the data of primary efficacy endpoint, secondary efficacy endpoints and safety endpoints. Additional targeted regimens may be added to the platform regimen as feasible as assessed by the investigators, and the protocol will be modified accordingly at that time.
The efficacy was evaluated by CT or MRI every 6 weeks (±1 week) according to RECIST 1.1. Subjects with CR or PR were required to have radiologic response confirmation at least 4 weeks. Tumor assessments were performed every 9 weeks (±1 week) after 36 weeks of treatment until disease progression, initiation of new antineoplastic therapy, withdrawal of consent, loss to follow-up, death, or the end of the study, whichever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SHR-A1811SHR-A1811 (HER2 ADC) |
| B | Experimental | Drug: SHR-A1921SHR-A1921 (TROP2 ADC) |
| C | Experimental | Drug: SHR-A2009SHR-A2009 (HER3 ADC) |
| D | Experimental | Drug: SHR-A2102SHR-A2102 (Nectin4 ADC) |
| E | Experimental | Drug: SHR-A1811, Drug: FamitinibSHR-A1811 (HER2 ADC) and Famitinib (VEGFR inhibitor) |
| F | Experimental | Drug: SHR-A1811, Dietary Supplement: Fat Module Formula for Special Medical PurposesSHR-A1811 (HER2 ADC) and Fat Module Formula for Special Medical Purposes (for Medium-Chain Triglyceride Supplementation) |
| G | Experimental | Drug: 9MW28219MW2821 (Nectin4 ADC) |
| H | Experimental | Drug: Trastuzumab (or biosimilar), Drug: 9MW28219MW2821 (Nectin4 ADC) + trastuzumab |
| I | Experimental | Drug: Disitamab Vedotin (RC48)Disitamab Vedotin (RC48) |
| J | Experimental | Drug: Treatment of physician's choice (TPC)Treatment of physician's choice (TPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years;
- Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
- Previously received ADCs;
- The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2. Participants with any hormone receptor (HR) status will be allowed on study.
- Prior endocrine therapy: Participants with HR-positive breast cancer must have received prior CDK4/6 inhibitor;
Key exclusion criteria (15 listed)
- Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
- Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
- A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
- Presence of the third space effusion (such as massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods;
- Participants with who had used immunosuppressive agents or systemic corticosteroids within 2 weeks before the first dose (dose> 10mg/day prednisone or other corticosteroids at the physiological dose of the drug), excluding nasal spray or inhaled corticosteroids;
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 |
|---|---|---|
| SHR-A1811A HER2-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | A, E, F |
| SHR-A1921A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | B |
| SHR-A2009A HER3-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | C |
| SHR-A2102A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | D |
| FamitinibA VEGFR inhibitor administered orally per the protocol. | Drug | E |
| Fat Module Formula for Special Medical PurposesThis nutritional formulation is composed primarily of medium-chain triglycerides (MCT), which are metabolized by the liver to induce nutritional ketosis, thereby significantly elevating circulating levels of beta-hydroxybutyrate (BHB). | Dietary supplement | F |
| Trastuzumab (or biosimilar)An anti-HER2 antibody, via intravenous (into the vein) infusion or subcutaneous per protocol. | Drug | H |
| 9MW2821A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | G, H |
| Disitamab Vedotin (RC48)A HER2-directed ADC, via intravenous (into the vein) infusion per protocol. | Drug | I |
| Treatment of physician's choice (TPC)Treatment of physician's choice (TPC), such as nab-paclitaxel, carboplatin, gemcitabine, capecitabine, vinorelbine, eribulin, etc., with specific dosages and administration methods determined at the investigator's discretion. | Drug | J |
Primary outcome
Objective response rate (ORR)
Time frame: The observation period related to this endpoint is up to 36 months.
Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined per protocol.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: The observation period related to this endpoint is up to 36 months.
Disease Control Rate (DCR)
Time frame: The observation period related to this endpoint is up to 36 months.
Clinical Benefit Rate (CBR)
Time frame: The observation period related to this endpoint is up to 36 months.
Duration of Response (DOR)
Time frame: The observation period related to this endpoint is up to 36 months.
Overall Survival (OS)
Time frame: The observation period related to this endpoint is up to 5 years.
Treatment-Related Toxicity Rate
Time frame: The observation period related to this endpoint is up to 36 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 3 Sep 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.
Zhimin Shao, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811, SHR-A1921 and SHR-A2009 in people with Advanced Breast Cancer and Metastatic Breast Cancer, run by Fudan University at 1 site 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 12 inclusion and 15 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Zhimin Shao, M.D. (86-21-64175590, Zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: The observation period related to this endpoint is up to 36 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 3 Sep 2026.