Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1/2NCT07104617
Study of TY-302 Capsules Combined With Abiraterone in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）
A Phase 1/2 study testing TY-302 and Abiraptor in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by TYK Medicines, Inc at 1 site in China.
Trial summary
This study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- TY-302 and Abiraptor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Nov 2026
- Phase
- Phase 1/2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrent metastasis (such as in the bladder, rectum, etc.) cannot be included.
- Testosterone levels ≤50ng/dL (≤1.75nmol/L) within 28 days prior to the first administration. If the patient has not undergone bilateral orchiectomy in the past, they must be undergoing and voluntarily continue to receive LHRH agonists/antagonists for androgen deprivation therapy throughout the study treatment period
- During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA > 1ng/ml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.
- Previous anti-tumor treatment must meet the following requirements: having failed in only one approved and marketed novel endocrine therapy in the past (referring to disease progression during the process of novel endocrine therapy; The definition of disease progression is the same as that of inclusion criterion 4), such as enzalutamide, apatamide, darotamide or rivelutamide, etc., and no previous treatment with abiraterone acetate has been received.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy > 3 months.
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- Have good organ functions, including:
- Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN (except for documented Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5×ULN, and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, ALT/AST≤5×ULN), albumin ≥3.0g/L; Renal function: Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate ≥50 mL/min (calculated according to the Cockcroft and Gault formula); Blood routine: PLT ≥ 100×109/L, ANC ≥ 1.5×109/L, WBC≥ 3.5×109/L and Hb ≥ 90g/L; The international normalized ratio (INR) is ≤1.5, and the activated partial prothrombin time (APTT) is ≤1.5×ULN (in the absence of anticoagulation therapy).
- agrees to maintain abstinence (control heterosexual sexual intercourse) or take contraceptive measures, and agrees not to donate sperm
- Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).
Who cannot join
- Patients with the following treatment:
- Received CDK4/6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib/G1T38, SHR6390, pirociclib) ;
- Received abirone acetate tablets and their analogues (CYP17 inhibitors, such as ketoconazole, etc.) or two or more novel endocrine therapies for prostate cancer;
- Received with strontium-89, samarium or radium-223 within 12 weeks prior to the first administration;
- Received systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) within 4 weeks prior to the first medication;
- Received traditional Chinese medicine preparations with anti-tumor therapeutic effects within one week before the first administration, or those who have received nitrourea or mitomycin treatment within six weeks before the first administration;
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- Received blood transfusion, albumin infusion or used hematopoietic growth factor within 2 weeks before the first administration;
- Within two weeks prior to the first administration, the patient has received treatment with drugs prohibited by the protocol [such as CYP3A strong suppressors, CYP3A strong inducers, and CYP3A-sensitive substrates with a narrow therapeutic index, etc.];
- Major surgery was performed within 28 days before the first administration of the drug , or surgery was performed when the surgical effect had not yet recovered at the time of screening or during the planned enrollment for treatment;
- Has received allogeneic transplants such as stem cell transplantation, bone marrow transplantation or liver transplantation in the past;
- Palliative radiotherapy was received within 2 weeks before the first administration;
- The first administration was within no more than five half-lives from the implantation of radioactive particles.
- In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding other malignant tumors that have been cured by radical treatment for at least 5 years;
- There is previous evidence indicating the existence of homologous recombination gene mutations (such as BRCA1, BRCA2, etc.)
- Known to be allergic to any excipients of TY-302 Capsules, or to Abiraterone acetate tablets and their excipients;
- There are contraindications for the use of prednisone (corticosteroid), such as active infection, active peptic ulcer, recent gastrointestinal anastomosis surgery, fracture, wound healing period, corneal ulcer, severe osteoporosis or other conditions. Or there may be diseases that require treatment with systemic steroid hormones (i.e., other corticosteroids at a physiological dose of more than 10mg/ day, such as prednisone or similar drugs);
- Patients whose progression of bone and soft tissue lesions cannot be evaluated, that is, those who meet both of the following criteria simultaneously:
- The bone scan showed a super bone imaging;
- According to RECIST1.1 criteria, there were no assessable soft tissue lesions (measurable or unmeasurable).
- The patient has any unstable or other disease or medical condition that may affect its safety or compliance with the study, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg), uncontrolled diabetes, active bleeding, ocular lesions Other serious diseases of the mental, nervous and other systems;
- Clinically obvious digestive tract abnormalities during screening may affect drug intake, transport or absorption (such as dysphagia, uncontrollable nausea and vomiting, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, etc.);
- Severe bone injury caused by tumor bone metastasis, with pathological fractures of important parts or spinal cord compression expected to occur in the near future within 6 months prior to knowledge;
- There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg/ day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included;
- Patients with clinically symptomatic third space effusion (such as pleural effusion, ascites, pericardial effusion) who require puncture and drainage, or those who have received puncture and drainage within 2 weeks before randomization or the first medication;
- At the time of screening, the toxicity of previous treatments had not yet recovered. According to CTCAE v5.0, there were still grade ≥2 AES (excluding special toxicities such as alopecia, fatigue, increased GGT, and increased ALP);
- Have severe cardiovascular diseases, including but not limited to:
- At rest, a 12-lead electrocardiogram (ECG) examination showed that the QTcF was ≥470ms;
- There are severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;
- Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA)) cardiac function grade ≥2, aortic dissection or other grade 3 cardiovascular events occurred within 6 months before the first administration;
- Left ventricular ejection fraction (LVEF) <50%;
- There is a history of thromboembolism or cerebrovascular events within 6 months before the first administration, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis or pulmonary embolism, etc;
- There was evidence of radiation pneumonitis, interstitial lung disease or interstitial pneumonia (ILD) requiring hormone therapy during the screening period, or drug-induced ILD, or any active ILD (such as acute exacerbation or progressive pneumonia/pulmonary fibrosis at baseline). Or pulmonary symptoms that the researchers consider unsuitable for enrollment, or high-risk factors that make it unsuitable for enrollment due to the possibility of interstitial lung disease;
- There was a severe infection within 4 weeks before the first administration, including but not limited to bacteremia requiring hospitalization and severe pneumonia; There was an active infection of CTCAE grade ≥2 that required systemic antibiotic treatment within 2 weeks before the first administration (except for local chronic infections or prophylactic antibiotic use that the investigator determined did not require treatment);
- Those with a history of active pulmonary tuberculosis infection within 6 months prior to the first administration;
- People infected with active human immunodeficiency virus (HIV), syphilis, hepatitis C virus (HCV) or hepatitis B virus (HBV). Active HBV, HCV and HIV infections are defined as:
- positive HBsAg and HBV DNA ≥500cps/ml/HBV DNA ≥1000u/ml;
- Anti-hcv antibody and HCV RNA positive;
- HIV antibody positive.
- Known history of alcohol or drug abuse or dependence; Mental disorder; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make the participants unsuitable for this study (such as not meeting the most beneficial treatment for the subjects, subject compliance, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Oral TY-302 Capsules Combined With Abiratone Acetate Tablets in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Novel Endocrine Therapy
This study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy
Read the detailed description
This is an open-label, multi-center, dose-escalation and expansion phase Ib/II study to evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with metastatic castration-resistant prostate cancer (mCRPC).
To evaluate the efficacy of TY-302 combined with Abiraterone tablets in subjects with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy
- Being tested
- TY-302, Abiraptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TY-302Drug
Take the specified dose (75mg or 100mg) orally once a day. Take it on an empty stomach in the morning with about 200 mL of warm water.
AbiraptorDrug
Take orally, 1000mg each time, once a day. Take it on an empty stomach in the morning with warm water, or take it orally at least two hours after fasting.
| Study group | Role | What they receive |
|---|---|---|
| TY-302+Abiraptor | Experimental | Find the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TY-302, given orally. • Increased dose cohorts from low dose to MTD, starting at 75mg Once a day. Abiraterone, 1000mg each time, once a day. Receives: Drug: TY-302; Drug: Abiraptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Escalation stage) Dose Limiting Toxicity (DLT)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.
Measured: Up to approximately 28 days
Maximum tolerated dose（MTD）
To determine the maximum tolerated dose for combination-agent escalation.
Measured: Within 28 days of the first dose
(Escalation stage) Recommended Phase 2 Dose（RP2D）
The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy collected during the dose escalation portion of the study
Measured: Within 28 days of the last patient dosed in escalation stage
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From Baseline up to 28 days after the end of the treatment
（Expansion stage) Progression-free survival (rPFS）
rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks.
Measured: Up to approximately 21 months
Secondary outcomes (4)
Prostate-specific antigen (PSA) response rate
The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria.
Measured: Up to approximately 21 months
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 21 months
Duration of response (DOR)
DOR is defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG is the appearance of >2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for >6 weeks.
Measured: Up to approximately 21 months
Objective response rate (ORR)
The ORR is defined as the percentage of participants with complete response (CR: disappearance of all target lesions per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); and no evidence of disease (NED) on base scan per Prostate Cancer Working Group (PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
Measured: Up to approximately 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Principal investigator, TYK Medicines, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104617
- Sponsor's protocol ID
- TYKM1602301
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Oral TY-302 Capsules Combined With Abiratone Acetate Tablets in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Novel Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07104617
- Acronym / sponsor ID
- TYKM1602301
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Aug 2025 (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 study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy
Detailed description
This is an open-label, multi-center, dose-escalation and expansion phase Ib/II study to evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with metastatic castration-resistant prostate cancer (mCRPC).
To evaluate the efficacy of TY-302 combined with Abiraterone tablets in subjects with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TY-302+Abiraptor | Experimental | Drug: TY-302, Drug: AbiraptorFind the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TY-302, given orally. • Increased dose cohorts from low dose to MTD, starting at 75mg Once a day. Abiraterone, 1000mg each time, once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years.
- Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrent metastasis (such as in the bladder, rectum, etc.) cannot be included.
- Testosterone levels ≤50ng/dL (≤1.75nmol/L) within 28 days prior to the first administration. If the patient has not undergone bilateral orchiectomy in the past, they must be undergoing and voluntarily continue to receive LHRH agonists/antagonists for androgen deprivation therapy throughout the study treatment period
- During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA > 1ng/ml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.
- Previous anti-tumor treatment must meet the following requirements: having failed in only one approved and marketed novel endocrine therapy in the past (referring to disease progression during the process of novel endocrine therapy; The definition of disease progression is the same as that of inclusion criterion 4), such as enzalutamide, apatamide, darotamide or rivelutamide, etc., and no previous treatment with abiraterone acetate has been received.
Key exclusion criteria (39 listed)
- Patients with the following treatment:
- In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding other malignant tumors that have been cured by radical treatment for at least 5 years;
- There is previous evidence indicating the existence of homologous recombination gene mutations (such as BRCA1, BRCA2, etc.)
- Known to be allergic to any excipients of TY-302 Capsules, or to Abiraterone acetate tablets and their excipients;
- There are contraindications for the use of prednisone (corticosteroid), such as active infection, active peptic ulcer, recent gastrointestinal anastomosis surgery, fracture, wound healing period, corneal ulcer, severe osteoporosis or other conditions. Or there may be diseases that require treatment with systemic steroid hormones (i.e., other corticosteroids at a physiological dose of more than 10mg/ day, such as prednisone or similar drugs);
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 |
|---|---|---|
| TY-302Take the specified dose (75mg or 100mg) orally once a day. Take it on an empty stomach in the morning with about 200 mL of warm water. | Drug | TY-302+Abiraptor |
| AbiraptorTake orally, 1000mg each time, once a day. Take it on an empty stomach in the morning with warm water, or take it orally at least two hours after fasting. | Drug | TY-302+Abiraptor |
Primary outcome
(Escalation stage) Dose Limiting Toxicity (DLT)
Time frame: Up to approximately 28 days
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.
Maximum tolerated dose（MTD）
Time frame: Within 28 days of the first dose
To determine the maximum tolerated dose for combination-agent escalation.
(Escalation stage) Recommended Phase 2 Dose（RP2D）
Time frame: Within 28 days of the last patient dosed in escalation stage
The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy collected during the dose escalation portion of the study
Adverse events (AEs)
Time frame: From Baseline up to 28 days after the end of the treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
（Expansion stage) Progression-free survival (rPFS）
Time frame: Up to approximately 21 months
rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks.
4 secondary outcomes
Prostate-specific antigen (PSA) response rate
Time frame: Up to approximately 21 months
Overall survival (OS)
Time frame: Up to approximately 21 months
Duration of response (DOR)
Time frame: Up to approximately 21 months
Objective response rate (ORR)
Time frame: Up to approximately 21 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 5 Aug 2025.
- 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.
Study Director principal investigator
TYK Medicines, Inc
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 TY-302 and Abiraptor in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by TYK Medicines, Inc 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 10 inclusion and 39 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: opening soon, as of the sponsor's last update on 5 Aug 2025. 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?
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 Zhu Ji, Doctor of Medicine (0571-88122222, zhuji@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Escalation stage) Dose Limiting Toxicity (DLT) (time frame: Up to approximately 28 days). 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 5 Aug 2025.