Clear Cell Renal CarcinomaPhase 1/2NCT06221774
Safety and Efficacy of TT-00420 Tablets Combined With Toripalimab Injection in Advanced Urological Tumors
A Phase 1/2 study testing TT-00420 + Toripalimab in people with Clear Cell Renal Carcinoma and Urothelial Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This Phase Ib/II clinical study is an open-label, multi-cohort, two-stage trial designed to assess the safety and efficacy of different doses of TT-00420 tablets in combination with Toripalimab injection for treating patients with advanced urological tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clear Cell Renal Carcinoma, Urothelial Carcinoma, Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- TT-00420 + Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Nov 2025
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation, sign the informed consent with good compliance.
- Age between 18-80 years.
- ECOG performance status of 0 or 1; expected survival of at least 3 months.
- Meeting all criteria for one of the following cancer types:
- Renal Clear Cell Carcinoma:
- Pathologically and radiologically confirmed metastatic or unresectable advanced clear cell renal cell carcinoma.
Show all 32Show fewer
- Failure after at least one systemic treatment for advanced or metastatic disease (including chemotherapy, targeted therapy, immunotherapy).
- At least one measurable lesion (RECIST 1.1).
- Urothelial Carcinoma:
- Pathologically and radiologically confirmed metastatic or unresectable advanced urothelial carcinoma (including bladder, ureter, renal pelvis, and urethra).
- Failure or refusal to receive at least one systemic chemotherapy for advanced, recurrent/metastatic disease.
- Progression after one PD-1/PD-L1 inhibitor treatment.
- At least one measurable lesion (RECIST 1.1).
- Prostate Cancer:
- Pathologically confirmed mCRPC with radiologically confirmed bone metastases or soft tissue metastases.
- Failure after at least one novel endocrine treatment for metastatic disease (including but not limited to abiraterone, enzalutamide).
- Failure or refusal of systemic chemotherapy.
- Baseline serum testosterone < 50 ng/dL (1.73 nmol/L).
- For participants without baseline soft tissue target lesions, baseline serum PSA ≥ 2 ng/mL and meeting PSA disease progression criteria per PCWG3.
- Adequate major organ function, laboratory test criteria:
- Hematology:
- Hemoglobin (HB) ≥ 90 g/L.
- Absolute Neutrophil Count (ANC) ≥ 1.5×109/L.
- Platelets (PLT) ≥ 75×109/L.
- Biochemistry:
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN for liver/bone metastasis).
- Total Bilirubin (TBIL) ≤ 1.5 × ULN.
- Serum Creatinine ≤ 1.5×ULN or Creatinine Clearance ≥ 30 mL/min.
- Coagulation:
- Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤ 1.5×ULN.
- Fertile women must agree to contraception during the study and for 3 months after the last administration of the study drug.
- [Failure Definition: Disease progression during treatment or after the last treatment, or intolerable toxicity due to side effects during treatment. Prior neoadjuvant or adjuvant treatment is allowed. If disease relapse or progression occurs within 6 months after the end of neoadjuvant/adjuvant treatment, it is considered a failure of first-line treatment for progressive disease.]
Who cannot join
- 1. Primary pure neuroendocrine cancer (except post-treatment neuroendocrine differentiation).
- 2. Other antitumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the start of the study treatment (except androgen deprivation therapy for prostate cancer patients, such as LHRH agonists or antagonists, bicalutamide, flutamide, etc.), or not yet recover from the toxicity of previous treatments (except ≤ G1 adverse events or tolerable G2 alopecia, fatigue/asthenia, and neuropathy caused by trauma at baseline).
- 3. Concurrent diseases/history:
- Clinically significant hemoptysis (> 50 mL per day) within 3 months before enrollment; significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood and above.
- Arteriovenous thrombotic events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except venous thrombosis caused by previous chemotherapy with venous catheterization judged by the investigator as cured), and pulmonary embolism.
- Hypertension not well controlled with stable dose antihypertensive treatment (systolic pressure > 150 mmHg or diastolic pressure > 100 mmHg); myocardial infarction, severe/unstable angina, NYHA class 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, prolonged QT interval, and symptomatic congestive heart failure within 6 months before baseline/screening.
Show all 19Show fewer
- Interstitial lung disease, non-infectious pneumonia, and other non-specific pneumonias (e.g., pulmonary fibrosis, interstitial pneumonia).
- Active infection requiring antibiotic treatment within 4 weeks before the first administration of the study drug, or unexplained fever > 38.5°C during screening or before the first administration of the study drug (fever due to tumor reasons judged by the investigator is allowed for enrollment); active tuberculosis.
- Live attenuated vaccine vaccination history within 28 days before the first study drug administration or expected live attenuated vaccine vaccination during the study (including COVID-19 vaccine).
- HIV infection or known acquired immunodeficiency syndrome (AIDS).
- Active HBV infection (other abnormal HBV serology tests besides hepatitis B surface antibody positive or ≥ ULN, HBV DNA copy number required to confirm activity) and/or HCV infection (HCV RNA copy number required to confirm activity if hepatitis C virus antibody is abnormal).
- Major surgery, extensive radiotherapy within 28 days before enrollment, or local palliative radiotherapy within 2 weeks.
- Baseline: ≥ G2 peripheral neuropathy; active brain metastases, carcinomatous meningitis, spinal cord compression, or imaging studies (CT or MRI) at screening showing brain or leptomeningeal disease (patients with brain metastases who have completed treatment and stabilized symptoms within 14 days before enrollment are allowed, but must be evaluated by cranial MRI, CT, or venography to confirm no symptoms of cerebral hemorrhage).
- Factors significantly affecting oral drug absorption, such as inability to swallow, history of total gastrectomy, short bowel syndrome, or clinically significant intestinal obstruction.
- Participants who have received or are preparing to receive allogeneic bone marrow transplantation or organ transplantation.
- History of severe allergy, immunostress, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; hypersensitivity or allergy to any component of Toripalimab injection.
- Active autoimmune diseases requiring systemic treatment within 2 years before the first administration of the study drug. Replacement therapy is not considered systemic treatment.
- Diagnosed with immunodeficiency or receiving systemic corticosteroid treatment or any form of immunosuppressive therapy, and continuing to use within 2 weeks before the first administration of the study drug.
- 4. Pregnant, breastfeeding, or planning to become pregnant during the study. 5. Other serious physical or mental illnesses or laboratory test abnormalities that may increase the risk of participating in the study, interfere with study results, or patients deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Hongqian Guo, PhD, 8613605171690, dr.ghq@nju.edu.cn
About this study
Official title: An Open-Label, Multi-Cohort, Two-Stage, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of TT-00420 Tablets Combined With Toripalimab Injection in Treating Advanced Urological Tumors
This Phase Ib/II clinical study is an open-label, multi-cohort, two-stage trial designed to assess the safety and efficacy of different doses of TT-00420 tablets in combination with Toripalimab injection for treating patients with advanced urological tumors. The study aims to evaluate the effectiveness of TT-00420 tablets at the optimal dose combined with Toripalimab in treating different types of advanced urological tumors.
- Conditions
- Clear Cell Renal Carcinoma, Urothelial Carcinoma, Metastatic Castration-resistant Prostate Cancer
- Being tested
- TT-00420 + Toripalimab
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-00420 + ToripalimabDrug
TT-00420 tablets in combination with Toripalimab injection
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib: dose optimization phase | Experimental | Approximately 12 participants will be enrolled and randomized 1:1 into two different dosage groups:
* Dose Group A (N=6): TT-00420 tablets 10mg QD + Toripalimab 240mg Q3W.
* Dose Group B (N=6): TT-00420 tablets 8mg QD + Toripalimab 240mg Q3W. Receives: Drug: TT-00420 + Toripalimab |
| Phase II | Experimental | Based on the safety and efficacy data from Phase Ib, further cohorts will enroll participants with specific tumor types at the optimal dose of TT-00420 tablets:
* Cohort 1 (N=10): Metastatic or unresectable advanced renal clear cell carcinoma (RCC).
* Cohort 2 (N=10): Metastatic or unresectable advanced urothelial carcinoma (UC).
* Cohort 3 (N=10): Metastatic castration-resistant prostate cancer (mCRPC). Receives: Drug: TT-00420 + Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib
To assess the incidence of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection.
Measured: Through study of Phase Ib, an average of 12 weeks
Types of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib
To assess the types of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection.
Measured: Through study of Phase Ib, an average of 12 weeks
Severity of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib
To assess the severity of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection per CTCAE V5.0.
Measured: Through study of Phase Ib, an average of 12 weeks
ORR in Phase II
Objective Response Rate (ORR) according to RECIST v1.1 for renal cell carcinoma, urothelial carcinoma, and prostate cancer (with baseline target lesions).
Measured: Through study of Phase II, an average of 1 year
PSA Response Rate in Phase II
PSA Response Rate (including PSA50 and PSA30, per PCWG3) for prostate cancer.
Measured: Through study of Phase II, an average of 1 year
Secondary outcomes (11)
ORR in Phase Ib
Objective Response Rate (ORR) according to RECIST v1.1 for renal cell carcinoma, urothelial carcinoma, and prostate cancer (with baseline target lesions).
Measured: Through study of Phase Ib, an average of 12 weeks
PSA Response Rate in Phase Ib
PSA Response Rate (PCWG3 for prostate cancer)
Measured: Through study of Phase Ib, an average of 12 weeks
DCR in Phase Ib
Disease Control Rate (DCR)
Measured: Through study of Phase Ib, an average of 12 weeks
PFS in months in Phase Ib
Progression-Free Survival (PFS)
Measured: Through study of Phase Ib, an average of 12 weeks
OS in months in Phase Ib
Overall Survival (OS)
Measured: Through study of Phase Ib, an average of 12 weeks
DCR in Phase II
Disease Control Rate (DCR)
Measured: Through study of Phase II, an average of 1 year
PFS in months in Phase II
Progression-Free Survival (PFS)
Measured: Through study of Phase II, an average of 1 year
OS in months in Phase II
Overall Survival (OS)
Measured: Through study of Phase II, an average of 1 year
Incidence of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase II
To assess the incidence of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection.
Measured: Through study of Phase II, an average of 1 year
Types of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase II
To assess the types of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection.
Measured: Through study of Phase II, an average of 1 year
Severity of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase II
To assess the severity of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection per CTCAE V5.0.
Measured: Through study of Phase II, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal CarcinomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221774
- Sponsor's protocol ID
- IUNU-PC-121
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Cohort, Two-Stage, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of TT-00420 Tablets Combined With Toripalimab Injection in Treating Advanced Urological Tumors
- ClinicalTrials.gov ID
- NCT06221774
- Acronym / sponsor ID
- IUNU-PC-121
- Conditions
- Clear Cell Renal Carcinoma, Urothelial Carcinoma, Metastatic Castration-resistant Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 24 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 Ib/II clinical study is an open-label, multi-cohort, two-stage trial designed to assess the safety and efficacy of different doses of TT-00420 tablets in combination with Toripalimab injection for treating patients with advanced urological tumors. The study aims to evaluate the effectiveness of TT-00420 tablets at the optimal dose combined with Toripalimab in treating different types of advanced urological tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ib: dose optimization phase | Experimental | Drug: TT-00420 + ToripalimabApproximately 12 participants will be enrolled and randomized 1:1 into two different dosage groups: * Dose Group A (N=6): TT-00420 tablets 10mg QD + Toripalimab 240mg Q3W. * Dose Group B (N=6): TT-00420 tablets 8mg QD + Toripalimab 240mg Q3W. |
| Phase II | Experimental | Drug: TT-00420 + ToripalimabBased on the safety and efficacy data from Phase Ib, further cohorts will enroll participants with specific tumor types at the optimal dose of TT-00420 tablets: * Cohort 1 (N=10): Metastatic or unresectable advanced renal clear cell carcinoma (RCC). * Cohort 2 (N=10): Metastatic or unresectable advanced urothelial carcinoma (UC). * Cohort 3 (N=10): Metastatic castration-resistant prostate cancer (mCRPC). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Voluntary participation, sign the informed consent with good compliance.
- Age between 18-80 years.
- ECOG performance status of 0 or 1; expected survival of at least 3 months.
- Meeting all criteria for one of the following cancer types:
- Adequate major organ function, laboratory test criteria:
Key exclusion criteria (19 listed)
- 1. Primary pure neuroendocrine cancer (except post-treatment neuroendocrine differentiation).
- 2. Other antitumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the start of the study treatment (except androgen deprivation therapy for prostate cancer patients, such as LHRH agonists or antagonists, bicalutamide, flutamide, etc.), or not yet recover from the toxicity of previous treatments (except ≤ G1 adverse events or tolerable G2 alopecia, fatigue/asthenia, and neuropathy caused by trauma at baseline).
- Clinically significant hemoptysis (> 50 mL per day) within 3 months before enrollment; significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood and above.
- Arteriovenous thrombotic events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except venous thrombosis caused by previous chemotherapy with venous catheterization judged by the investigator as cured), and pulmonary embolism.
- Hypertension not well controlled with stable dose antihypertensive treatment (systolic pressure > 150 mmHg or diastolic pressure > 100 mmHg); myocardial infarction, severe/unstable angina, NYHA class 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, prolonged QT interval, and symptomatic congestive heart failure within 6 months before baseline/screening.
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 |
|---|---|---|
| TT-00420 + ToripalimabTT-00420 tablets in combination with Toripalimab injection | Drug | Phase II, Phase Ib: dose optimization phase |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
To assess the incidence of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection.
Types of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
To assess the types of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection.
Severity of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
To assess the severity of adverse events at different doses of TT-00420 tablets combined with Toripalimab Injection per CTCAE V5.0.
ORR in Phase II
Time frame: Through study of Phase II, an average of 1 year
Objective Response Rate (ORR) according to RECIST v1.1 for renal cell carcinoma, urothelial carcinoma, and prostate cancer (with baseline target lesions).
PSA Response Rate in Phase II
Time frame: Through study of Phase II, an average of 1 year
PSA Response Rate (including PSA50 and PSA30, per PCWG3) for prostate cancer.
11 secondary outcomes
ORR in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
PSA Response Rate in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
DCR in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
PFS in months in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
OS in months in Phase Ib
Time frame: Through study of Phase Ib, an average of 12 weeks
DCR in Phase II
Time frame: Through study of Phase II, an average of 1 year
PFS in months in Phase II
Time frame: Through study of Phase II, an average of 1 year
OS in months in Phase II
Time frame: Through study of Phase II, an average of 1 year
Incidence of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase II
Time frame: Through study of Phase II, an average of 1 year
Types of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase II
Time frame: Through study of Phase II, an average of 1 year
Severity of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase II
Time frame: Through study of Phase II, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
Related trials for Clear Cell Renal Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TT-00420 + Toripalimab in people with Clear Cell Renal Carcinoma and Urothelial Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 32 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongqian Guo, PhD (8613605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events and Treatment-Related Adverse Events [Safety and Tolerability] in Phase Ib (time frame: Through study of Phase Ib, an average of 12 weeks). The study lists 5 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 24 Jan 2024.