Soft Tissue SarcomaPhase 2NCT05549921
Phase II Study of TAEST16001 in Soft Tissue Sarcoma
A Phase 2 study testing NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy) in people with Soft Tissue Sarcoma, run by Sun Yat-sen University at 2 sites in China.
Trial summary
The main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesChina
- Study dates
- 8 Jul 2022to 1 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before any research-related operations, they should sign the informed consent Consent Form (ICF) (Genotype and Tumor Antigen Screening and Primary Screening);
- Age ≥18 years, and ≤70 years;
- His/cytology confirmed, unresectable or metastatic soft tissue sarcoma;
- The current stage is the failure of standard treatment (disease progression or recurrence or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lack of effective treatment methods, specifically: In addition to acinar soft tissue sarcoma and for pathological subtypes other than epithelioid sarcoma, at least adriamycin or doxorubicin combined with ifosfamide standard chemotherapy regimen should fail or not tolerate chemotherapy; For acinar soft tissue sarcoma and epithelioid sarcoma, need failure or intolerance of previous targeted drugs [anti-angiogenesis such as Anlotinib, pazopanib, etc.]; Note: Treatment failure refers to disease progression or inability during treatment or within 3 months of the last treatment Tolerable; disease progression in patients with neoadjuvant or adjuvant therapy > 6 months after the end of treatment can be considered first-line therapy;
- At least 1 measurable lesion (according to RECIST1.1 criteria [see Appendix 4 for details]);
- Genotype and tumor antigen screening must meet the following 2 criteria: HLA-A*02:01 positive; NY-ESO-1* positive: immunohistochemical staining positive cells are ≥20%;
Show all 10Show fewer
- ECOG score of 0-1 and expected survival period of more than 3 months;
- Echocardiography showed left ventricular ejection fraction ≥ 50%;
- Laboratory test results should at least meet the following specified indicators: White blood cell count ≥ 3.0×109 /L; Absolute neutrophil count (ANC) ≥ 1.5×109/L (without G-CSF and GM-CSF support, at least 14 days before lymphadenectomy); Absolute lymphocyte count (ALC) ≥ 0.7× 109/L; Platelet (PLT) ≥ 75×109/L (no blood transfusion therapy 14 days before lymphadenectomy chemotherapy); hemoglobin ≥ 9 g/dL (no blood transfusion therapy 14 days before lymphoid clearing chemotherapy); Coagulation International Normalized Ratio (INR) ≤ 1.5×ULN unless anticoagulant therapy;Partial prothrombin time (APTT) ≤ 1.5×ULN unless anticoagulant therapy; Serum creatinine ≤ 1.5 mg /dL (or 132.6 μmol/L); Creatinine clearance ≥60 mL/min; Aspartate aminotransferase (AST/SGOT)≤2.5×ULN; Alanine aminotransferase (ALT/SGPT)≤2.5×ULN; Total bile red Prime (TBIL)≤1.5×U LN; Note: If patients with liver metastases or patients with primary liver tumor lesions, aspartate aminotransferase and alanine aminotransferase should be ≤5× ULN;
- Females of childbearing age who have not received sterilization before menopause must agree to be removed from the study treatment (clearing). effective contraceptive measures should be used from the beginning of the last cell infusion to one year after the last cell infusion, and the serum pregnancy test was negative within 14 days before the first cell infusion; ) and up to one year after the last cell infusion, use effective contraception.
Who cannot join
- Received the last leukocyte apheresis within 4 weeks. Anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, tumor embolization or traditional Chinese medicine with anti-tumor indications, etc.); immunotherapy within 1 month before the signing of the main informed consent;
- 4 days before cell infusion received live attenuated vaccine within 1 week;
- Patients with ≥3 bone metastases;
- Known to have allergic reactions to any components used in the treatment of this study;
- No previous surgery or treatment-related adverse reactions recovered to <Grade 2 CTCAE v5.0;
- Patients with a history of meningeal metastasis or central nervous system metastasis, or patients with clear underlying diseases of the central nervous system within 6 months before cell reinfusion, and left significant symptoms;
Show all 20Show fewer
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant (eg active) cardiovascular and cerebrovascular diseases, such as cerebrovascular accident within 1 month), myocardial infarction (within 6 months before signing the main informed consent), unstable angina, congestive heart failure with New York Heart Association (NYHA) class II or above, or severe arrhythmia that cannot be treated with drugs Control or have potential impact on study treatment; ECG results show clinically significant abnormality or average QTcF ≥ 450 ms in 3 consecutive times (at least 5 minutes between each time) (see Appendix 2 for the formula);
- Combined with other serious devices;
- Patients with systemic active infections that require treatment, including but not limited to active tuberculosis, known HIV-positive patients or clinically active hepatitis A, B, and C patients, including virus carriers;
- Patients with autoimmune diseases: those with a history of inflammatory bowel disease and a history of autoimmune diseases judged by the investigator to be unsuitable for this study, such as systemic lupus erythematosus, vasculitis, and infiltrative lung disease, should be excluded ( (except for vitiligo and psoriasis that do not require systemic immunosuppressive therapy);
- G-CSF or GM-CSF has been used within 2 weeks before leukapheresis, or within 4 weeks before cell reinfusion and planned to be used during the study period (If there is long-term use) systemic cortisone steroids, hydroxyurea, immunomodulatory drugs (eg: alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.);
- Organ isotypes History of transplantation, allogeneic stem cell transplantation and renal replacement therapy;
- Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
- Known alcohol and/or drug abuser;
- Pregnant or lactating women;
- Suffering from any co-existing medical conditions or diseases that the investigators determined may affect the conduct of this trial.
- Subjects with no legal capacity/restricted capacity;
- Previously received treatment targeting NY-ESO-1, or received cellular immunotherapy within 12 months before cell reinfusion, investigator Patients deemed unsuitable for enrollment;
- Received immunotherapy (immune checkpoint blockade therapy: such as PD-1, PD-L1 antibody treatment, etc.) within 3 months before cell reinfusion;
- Patients judged by the investigator Difficulty completing all visits or procedures (including follow-up periods) required by the study protocol, or insufficient compliance to participate in this study; or patients deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Cancer Hospital & Institute
Beijing, 100142
Sun Yat-Sen Univerisity Cancer Center
Guangzhou, Guangdong
About this study
Official title: TAEST16001 in Patients With Soft Tissue Sarcoma With Positive NY-ESO-1 Expression (Genotype: HLA-A*02:01): an Multi-center, Open-label and Single Arm Phase II Study
The main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression.
Read the detailed description
This is a single-arm, open label, multi-center, phase II study. The investigators include advanced soft tissue sarcoma with failure in standard treatment or no recommended standard therapy.
TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma patients and 55% melanoma patients benefit from this treatment, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy.
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. NY-ESO-1 expression was also found in 88.2% of myxoid liposarcomas, 61.1% of synovial sarcomas, 31.3% of osteosarcomas, 21.4% of pleomorphic liposarcomas, 16.7% of desmoplastic small round cell tumors, and 14.3% of chondrosarcomas. Although the NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients and the phase I trial has been performed, its effect and safety on advanced soft tissue sarcoma is still unknown.
The patients must meet the two criteria: HLA-A*0201positive and NY-ESO-1 positive cells≥20% by immunohistochemistry.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)Biological
NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)
| Study group | Role | What they receive |
|---|---|---|
| NY-ESO-1 TCR Specific T cell Therapy | Experimental | This research is divided into two stages, Stage 1 and Stage 2, respectively. In Stage 1, 14 patients with advanced soft tissue sarcoma with positive expression of tumor antigen NY-ESO-1 and HLA-A*02:01 genotype were enrolled. A further 42 patients will be enrolled in Stage 2, where the primary efficacy analysis will be performed at 3 months after the completion of cell reinfusion in the last subject, with a target ORR of 25%. Receives: Biological: NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The objective response rate (ORR), as assessed by an independent imaging evaluation committee (IRC), was used as the endpoint (response evaluation criteria based on solid tumors, version 1.1 [RECIST1.1]) to evaluate the TAEST16001 cell therapy tissue genotype as HLA-A*02:01 and tumor antigen NY-ESO-1 Efficacy of positive expression in patients with advanced soft tissue sarcoma.
Measured: 270 days
Secondary outcomes (12)
Disease control rate (DCR)
Assessed by in all patients with advanced soft tissue sarcoma who received TAEST16001 cell reinfusion, according to RECIST.
Measured: 270 days
Progression-free survival (PFS)
Assessed by in all patients with advanced soft tissue sarcoma who received TAEST16001 cell reinfusion.
Measured: 270 days
Duration of response (DOR)
Assessed by in all patients with advanced soft tissue sarcoma who received TAEST16001 cell reinfusion, according to RECIST.
Measured: 270 days
Time to tumor response (TTR)
Assessed by in all patients with advanced soft tissue sarcoma who received TAEST16001 cell reinfusion, according to RECIST.
Measured: 270 days
Overall survival (OS)
Assessed by IRC and investigator in all patients with advanced soft tissue sarcoma who received TAEST16001 cell reinfusion.
Measured: 270 days
Number of participants with other abnormal laboratory values and/or adverse events that are related to treatment
According to CTCAE 5.0 criteria.
Measured: 270 days
Maximum Plasma Concentration (Cmax)
To observe the proliferation and persistence of TAEST16001 cells in vivo.
Measured: 270 days
Maximum time to peak (Tmax)
To observe the proliferation and persistence of TAEST16001 cells in vivo.
Measured: 270 days
Activity of T lymphocyte subsets
To observe the influence of TAEST16001 cells on human immunological activity.
Measured: 270 days
Activity of peripheral blood antigen specific cytotoxic lymphocyte (CTL)
To observe the influence of TAEST16001 cells on human immunological activity.
Measured: 270 days
Activity of effector T cells
To observe the influence of TAEST16001 cells on human immunological activity.
Measured: 270 days
Life quality scale
According to European Organization for Research on Treatment of Cancer (EORTC) QLQ-C30 life quality scale, 30 items were divided into 5 functional domains (physical, role, cognitive, emotional and social functions), 3 symptom domains (fatigue, pain, nausea and vomiting), 1 general health/quality of life domain and 6 single domains. The score for each domain is obtained by summing the scores of items included in each domain and dividing by the number of items included. The final total scores range from 0 to 100 by standardizing the conversion of the raw scores. Higher scores in the functional and general health domains indicate better functioning and quality of life, and higher scores in the symptom domain indicate more symptoms or problems (worse quality of life).
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Jul 2022
- Primary completion23 Jul 2025
- Study completion1 Aug 2025
Why it stopped: The study was terminated due to initiation of a new clinical trial with an updated study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Xiangxue Precision Medical Technology Co., Ltd.
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
- Investigators
- Xing Zhang, PhD, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549921
- Sponsor's protocol ID
- TAEST16001 Phase II
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2022
- Last updated
- 12 Jun 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAEST16001 in Patients With Soft Tissue Sarcoma With Positive NY-ESO-1 Expression (Genotype: HLA-A*02:01): an Multi-center, Open-label and Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT05549921
- Acronym / sponsor ID
- TAEST16001 Phase II
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to initiation of a new clinical trial with an updated study design.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Xiangxue Precision Medical Technology Co., Ltd.
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 22 Sep 2022 (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 main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression.
Detailed description
This is a single-arm, open label, multi-center, phase II study. The investigators include advanced soft tissue sarcoma with failure in standard treatment or no recommended standard therapy.
TCR-T cell therapy has made a breakthrough for tumors in recent years. Phase I/II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma, conducted by the Rosenberg team at the National Cancer Institute, showed that 61% Synovial cell sarcoma patients and 55% melanoma patients benefit from this treatment, without severe side effects found in T cell receptor (TCR) transduced T-Cell Immunotherapy.
This clinical trial is mainly focused on cancer-testis antigen, because it is not expressed in normal cells. NY-ESO-1 antigen as one member of cancer-testis antigen, is commonly expressed in 10-50% of melanoma, lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of multiple myeloma cases, and 70-80% of synovial sarcoma. NY-ESO-1 expression was also found in 88.2% of myxoid liposarcomas, 61.1% of synovial sarcomas, 31.3% of osteosarcomas, 21.4% of pleomorphic liposarcomas, 16.7% of desmoplastic small round cell tumors, and 14.3% of chondrosarcomas. Although the NY-ESO-1 TCR cell therapy for synovial sarcoma and melanoma has benefited many patients and the phase I trial has been performed, its effect and safety on advanced soft tissue sarcoma is still unknown.
The patients must meet the two criteria: HLA-A*0201positive and NY-ESO-1 positive cells≥20% by immunohistochemistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NY-ESO-1 TCR Specific T cell Therapy | Experimental | Biological: NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)This research is divided into two stages, Stage 1 and Stage 2, respectively. In Stage 1, 14 patients with advanced soft tissue sarcoma with positive expression of tumor antigen NY-ESO-1 and HLA-A*02:01 genotype were enrolled. A further 42 patients will be enrolled in Stage 2, where the primary efficacy analysis will be performed at 3 months after the completion of cell reinfusion in the last subject, with a target ORR of 25%. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Before any research-related operations, they should sign the informed consent Consent Form (ICF) (Genotype and Tumor Antigen Screening and Primary Screening);
- Age ≥18 years, and ≤70 years;
- His/cytology confirmed, unresectable or metastatic soft tissue sarcoma;
- The current stage is the failure of standard treatment (disease progression or recurrence or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lack of effective treatment methods, specifically: In addition to acinar soft tissue sarcoma and for pathological subtypes other than epithelioid sarcoma, at least adriamycin or doxorubicin combined with ifosfamide standard chemotherapy regimen should fail or not tolerate chemotherapy; For acinar soft tissue sarcoma and epithelioid sarcoma, need failure or intolerance of previous targeted drugs [anti-angiogenesis such as Anlotinib, pazopanib, etc.]; Note: Treatment failure refers to disease progression or inability during treatment or within 3 months of the last treatment Tolerable; disease progression in patients with neoadjuvant or adjuvant therapy > 6 months after the end of treatment can be considered first-line therapy;
- At least 1 measurable lesion (according to RECIST1.1 criteria [see Appendix 4 for details]);
Key exclusion criteria (20 listed)
- Received the last leukocyte apheresis within 4 weeks. Anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, tumor embolization or traditional Chinese medicine with anti-tumor indications, etc.); immunotherapy within 1 month before the signing of the main informed consent;
- 4 days before cell infusion received live attenuated vaccine within 1 week;
- Patients with ≥3 bone metastases;
- Known to have allergic reactions to any components used in the treatment of this study;
- No previous surgery or treatment-related adverse reactions recovered to <Grade 2 CTCAE v5.0;
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 |
|---|---|---|
| NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy) | Biological | NY-ESO-1 TCR Specific T cell Therapy |
Primary outcome
Objective response rate
Time frame: 270 days
The objective response rate (ORR), as assessed by an independent imaging evaluation committee (IRC), was used as the endpoint (response evaluation criteria based on solid tumors, version 1.1 [RECIST1.1]) to evaluate the TAEST16001 cell therapy tissue genotype as HLA-A*02:01 and tumor antigen NY-ESO-1 Efficacy of positive expression in patients with advanced soft tissue sarcoma.
12 secondary outcomes
Disease control rate (DCR)
Time frame: 270 days
Progression-free survival (PFS)
Time frame: 270 days
Duration of response (DOR)
Time frame: 270 days
Time to tumor response (TTR)
Time frame: 270 days
Overall survival (OS)
Time frame: 270 days
Number of participants with other abnormal laboratory values and/or adverse events that are related to treatment
Time frame: 270 days
Maximum Plasma Concentration (Cmax)
Time frame: 270 days
Maximum time to peak (Tmax)
Time frame: 270 days
Activity of T lymphocyte subsets
Time frame: 270 days
Activity of peripheral blood antigen specific cytotoxic lymphocyte (CTL)
Time frame: 270 days
Activity of effector T cells
Time frame: 270 days
Life quality scale
Time frame: 270 days
Results and safety
The study was stopped early (reason given: The study was terminated due to initiation of a new clinical trial with an updated study design.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Soft Tissue Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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. This study is not recruiting at the moment.
Xing Zhang, PhD, MD principal investigator
Sun Yat-Sen University Cancer Center
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 NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy) in people with Soft Tissue Sarcoma, run by Sun Yat-sen University 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 10 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 Jun 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. 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?
The study was stopped early (reason given: The study was terminated due to initiation of a new clinical trial with an updated study design.). Results are not available in the source record.
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?
Objective response rate (time frame: 270 days). 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 12 Jun 2026.