Advanced Solid TumorsPhase 1/2NCT06376136

A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors

A Phase 1/2 study testing BAT8010 for Injection and BAT1006 for Injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: BAT8010 for Injection and BAT1006 for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 218 participants
Where: 1 siteChina
Study dates: 8 May 2024to 30 May 2028
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age ≥18 years old, male and female, voluntarily sign informed consent;
Estimated survival ≥3 months as assessed by the investigators;
the Eastern UnitedStates Cancer Consortium (ECOG) physicalstatu sscore requirements of 0 to 1 points;
Included in the crowd:
Dose escalation stage: Patients with HER-2 expression confirmed by histopathology and cytopathology (including IHC3+, IHC2+/FISH+ and IHC2+/FISH-) who have failed standard therapy or have no standard treatment options or are not suitable for standard therapy at this stage, The climbing stage includes but is not limited to breast cancer, stomach cancer, non-small cell lung cancer, biliary tract cancer, colorectal cancer, urothelial carcinoma, etc.
Dose expansion phase: divided into 3 cohorts i. Cohort A: Patients with breast cancer with HER-2 expression (including IHC3+, IHC2+/FISH+ and IHC2+/FISH-) confirmed by histopathology and cytopathology after failure of standard treatment or no standard treatment regimen or unsuitable for standard treatment at this stage; ii. Cohort B: Patients with histopathologically confirmed and inoperable locally advanced or metastatic urothelial carcinoma, including urinary bladder, pelvis, ureter, and urethral origin with HER-2 expression (including IHC3+, IHC2+/FISH+, and IHC2+/FISH-); iii. Cohort C: patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) with disease progression after standard therapy, or histologically or cytologically proven metastatic or unresectable locally advanced or metastatic HER-2 expression (including IHC3+, IHC2+/FISH+, and IHC2+/FISH-) who are intolerant to standard therapy;
the dose escalation phase must have an evaluable tumor lesion, and the dose expansion phase must have at least one measurable tumor lesion (according to RECIST 1.1 criteria);
Pregnant women must have a negative pregnancy test during the screening period, before first dosing, and on the first day of each cycle. Consent must be given to the use of effective contraceptive methods to prevent pregnancy. No egg donation. And willing to take effective contraceptive methods to prevent pregnancy after signing the informed consent until 90 days after the last dosing of the study.

Who cannot join

During previous treatment with HER2-targeted drugs such as trastuzumab or pertuzumab, T-DM1, vedicitumab or Enhertu, as well as topoisomerase I inhibitors (such as irinotecan), grade 3 aes (including but not limited to infusion reactions or allergic reactions) that were determined to be treaty-related or of unknown drug relationship, or L after treatment VEF < 50%;
Participants who had previously received doxorubicin with cumulative dose > 360 mg/m2 or equivalent anthracyclines;
Before the first administration of the investigational drug, AE (CTCAE5.0) caused by previous antitumor therapy still had grade 1, except for the following cases: a. Hair loss; b Pigmentation; c. Patients with distal toxicity caused by chemotherapy and radiotherapy who can not be further recovered by judgment;
primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or a history of epilepsy. Patients with asymptomatic or asymptomatic central nervous system metastases under clinical control or who have symptoms but are judged to be stable by the investigators can be included, provided that the following conditions are met :a. The clinical symptoms were stable ≥4 weeks before the first dose. b. Brain MRI enhancement showed no evidence of progression of central nervous system disease within 4 weeks prior to initial administration; c. Antiepileptic drugs, hormones and other drugs have been stopped ≥2 weeks before the first administration;
Major surgical procedures were performed within 28 days prior to the first use of the study drug, or if postoperative complications persist after 21 days;
Subjects who have had a severe infection within 4 weeks prior to first dosing, or who have any signs and symptoms of active infection within 2 weeks prior to first dosing;

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Subjects who have not been treated or are being treated for tuberculosis, including but not limited to tuberculosis (those who have been treated with standardized anti-tuberculosis therapy and have been confirmed cured by the investigator), a history of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency diseases, or a history of organ transplantation;
there are infected with the following diseases: active hepatitis B virus infection [hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus deoxyribonucleic acid (HBV-DNA) test >200 IU/ml or 103 copies /ml (or > the normal high value of the study center detection)]; Hepatitis C virus infection [HCV antibody and viral ribonucleic acid (HCV-RNA) test positive]; Treponema pallidum antibody positive and RPR positive;
Patients with symptomatic congestive heart failure (NYHA grade II to IV) or severe arrhythmias requiring treatment (12-lead ECG QTc extension of 450 ms [male], 470 ms [female]), myocardial infarction, unstable angina in the last 6 months. Except atrial fibrillation or paroxysmal supraventricular tachycardia;
Patients with a history of non-infectious pneumonia requiring glucocorticoid therapy or with current interstitial lung disease;
the presence of any other serious underlying medical conditions (e.g. Gilbert's syndrome, uncontrolled diabetes, uncontrolled hypertension, active gastric ulcers, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation and coagulation disorders), psychiatric/psychological/family factors that the investigator determines may influence screening, treatment, and follow-up. Affect compliance or put patients at high risk for treatment-related complications;
The previous anti-tumor therapy (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization, etc.) is less than 28 days from the first study (or if the half-life of the drug is 5 times shorter than 28 days, the sponsor and the researcher shall decide whether to include it according to the specific analysis of the specific circumstances). Note that castration for prostate cancer and bisphosphonate or dinomumab for osteoporosis are permitted. Patients whose previous palliative radiotherapy was less than 7 days removed from the first study, or whose previous wide-field radiotherapy was less than 28 days removed from the first study, or who had not recovered from the side effects of radiotherapy as determined by the investigators;
Therapeutic radiopharma use must be discontinued 8 weeks before the first study administration;
Known allergy or intolerance to the investigational drug or its excipients;
Pregnant or lactating women;
Subjects considered unsuitable for participation in this study by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong

Other trials in China

About this study

Official title: An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study

This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study.

Conditions: Advanced Solid Tumors
Being tested: BAT8010 for Injection, BAT1006 for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAT8010 for InjectionDrug
Intravenous
BAT1006 for InjectionDrug
Intravenous

Study groups in NCT06376136
Study group	Role	What they receive
A/ Standard 3+3 2.1mg/kg of BAT8010	Experimental	Drug: BAT8010, Dosage: 2.1mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection
B/ Standard 3+3 2.4mg/kg of BAT8010	Experimental	Drug: BAT8010, Dosage: 2.4mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection
C/ Standard 3+3 2.7 mg/kg of BAT8010	Experimental	Drug: BAT8010, Dosage: 2.7 mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection
Standard 3+3 15 mg/kg of BAT1006	Experimental	Drug: BAT1006, Dosage: 15 mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT1006 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicity (DLT)
DLT events and their incidence.
Measured: The first administration cycle(21 days)
vital signs
Number of participants with abnormal vital signs
Measured: Through study completion, 1 year
Physical examination
Number of participants with abnormal physical examination
Measured: Through study completion, 1 year
Adverse events
Number of cases with all adverse medical events that occur after the subject receives the investigational drug
Measured: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier，assessed up to 1 year
Clinical laboratory tests
Number of participants with abnormal Clinical laboratory tests
Measured: Through study completion, 1 year
Number of participants with abnormal clinical auxiliary tests
Clinical auxiliary tests
Measured: Through study completion, 1 year
Duration of Response(DOR)
DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR
Measured: Through study completion, 1 year
Disease Control Rate (DCR)
The proportion of patients with tumor reduction or stability maintained for a certain period, including cases of complete response (CR), partial response (PR), and stable disease (SD)
Measured: Through study completion, 1 year

Secondary outcomes (6)

Pharmacokinetic
Level of Cmax
Measured: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Pharmacokinetic
Level of Tmax
Measured: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Pharmacokinetic
Level of CL
Measured: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Pharmacokinetic
Level of T1/2
Measured: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Antibody
Level of ADA
Measured: At the end of Cycle 1 Day 1, Cycle 2 Day 1，Cycle 3 Day 1 ,Cycle 5 Day 1，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Antibody
Level of Nab
Measured: At the end of Cycle 1 Day 1, Cycle 2 Day 1，Cycle 3 Day 1 ,Cycle 5 Day 1，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202430 May 2028

First posted19 Apr 2024
Study start8 May 2024
Primary completion29 Feb 2028 (estimated)
Study completion30 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 218 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06376136
Sponsor's protocol ID: BAT-8010+1006-001-CR
Status last verified: Sep 2026
First submitted: 17 Apr 2024
Last updated: 30 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study
ClinicalTrials.gov ID: NCT06376136
Acronym / sponsor ID: BAT-8010+1006-001-CR
Conditions: Advanced Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 218 participants (estimated)
Lead sponsor: Bio-Thera SolutionsIndustry (pharma, biotech, devices)
Study start: 8 May 2024 (actual)
Primary completion: 29 Feb 2028 (estimated)
Study completion: 30 May 2028 (estimated)
First posted: 19 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
A/ Standard 3+3 2.1mg/kg of BAT8010	Experimental	Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 2.1mg/kg, Frequency: once every 3 weeks, Duration: 1year
B/ Standard 3+3 2.4mg/kg of BAT8010	Experimental	Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 2.4mg/kg, Frequency: once every 3 weeks, Duration: 1year
C/ Standard 3+3 2.7 mg/kg of BAT8010	Experimental	Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 2.7 mg/kg, Frequency: once every 3 weeks, Duration: 1year
Standard 3+3 15 mg/kg of BAT1006	Experimental	Drug: BAT1006 for InjectionDrug: BAT1006, Dosage: 15 mg/kg, Frequency: once every 3 weeks, Duration: 1year

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

age ≥18 years old, male and female, voluntarily sign informed consent;
Estimated survival ≥3 months as assessed by the investigators;
the Eastern UnitedStates Cancer Consortium (ECOG) physicalstatu sscore requirements of 0 to 1 points;
Included in the crowd:
the dose escalation phase must have an evaluable tumor lesion, and the dose expansion phase must have at least one measurable tumor lesion (according to RECIST 1.1 criteria);

Key exclusion criteria (16 listed)

During previous treatment with HER2-targeted drugs such as trastuzumab or pertuzumab, T-DM1, vedicitumab or Enhertu, as well as topoisomerase I inhibitors (such as irinotecan), grade 3 aes (including but not limited to infusion reactions or allergic reactions) that were determined to be treaty-related or of unknown drug relationship, or L after treatment VEF < 50%;
Participants who had previously received doxorubicin with cumulative dose > 360 mg/m2 or equivalent anthracyclines;
Before the first administration of the investigational drug, AE (CTCAE5.0) caused by previous antitumor therapy still had grade 1, except for the following cases: a. Hair loss; b Pigmentation; c. Patients with distal toxicity caused by chemotherapy and radiotherapy who can not be further recovered by judgment;
primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or a history of epilepsy. Patients with asymptomatic or asymptomatic central nervous system metastases under clinical control or who have symptoms but are judged to be stable by the investigators can be included, provided that the following conditions are met :a. The clinical symptoms were stable ≥4 weeks before the first dose. b. Brain MRI enhancement showed no evidence of progression of central nervous system disease within 4 weeks prior to initial administration; c. Antiepileptic drugs, hormones and other drugs have been stopped ≥2 weeks before the first administration;
Major surgical procedures were performed within 28 days prior to the first use of the study drug, or if postoperative complications persist after 21 days;

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
BAT8010 for InjectionIntravenous	Drug	A/ Standard 3+3 2.1mg/kg of BAT8010, B/ Standard 3+3 2.4mg/kg of BAT8010, C/ Standard 3+3 2.7 mg/kg of BAT8010
BAT1006 for InjectionIntravenous	Drug	Standard 3+3 15 mg/kg of BAT1006

Primary outcome

Dose-limiting toxicity (DLT)
Time frame: The first administration cycle(21 days)
DLT events and their incidence.
vital signs
Time frame: Through study completion, 1 year
Number of participants with abnormal vital signs
Physical examination
Time frame: Through study completion, 1 year
Number of participants with abnormal physical examination
Adverse events
Time frame: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier，assessed up to 1 year
Number of cases with all adverse medical events that occur after the subject receives the investigational drug
Clinical laboratory tests
Time frame: Through study completion, 1 year
Number of participants with abnormal Clinical laboratory tests
Number of participants with abnormal clinical auxiliary tests
Time frame: Through study completion, 1 year
Clinical auxiliary tests
Duration of Response(DOR)
Time frame: Through study completion, 1 year
DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR
Disease Control Rate (DCR)
Time frame: Through study completion, 1 year
The proportion of patients with tumor reduction or stability maintained for a certain period, including cases of complete response (CR), partial response (PR), and stable disease (SD)

6 secondary outcomes

Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 to Cycle 1 Day 4, Cycle 1 Day 8，Cycle 1 Day 15, Cycle 2 Day 1，Cycle 3 Day 1 to Cycle 3 Day 3 , Cycle 3 Day 8 , Cycle 3 Day 15，Cycle 4 Day 1 ,Cycle 5 Day 1 ，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Antibody
Time frame: At the end of Cycle 1 Day 1, Cycle 2 Day 1，Cycle 3 Day 1 ,Cycle 5 Day 1，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 weeks)
Antibody
Time frame: At the end of Cycle 1 Day 1, Cycle 2 Day 1，Cycle 3 Day 1 ,Cycle 5 Day 1，Cycle 6 Day 1，EOT until 17 cycles (one cycle equals 2 week

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 30 Sep 2026.

Related trials for Advanced Solid Tumors

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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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. This study is not recruiting at the moment.

Ruihua Xu principal investigator

Medical Ethics Committee of Sun Yat-sen University Cancer Center

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 BAT8010 for Injection and BAT1006 for Injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions 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 8 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 30 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 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?

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?

Dose-limiting toxicity (DLT) (time frame: The first administration cycle(21 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376136.

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 30 Sep 2026.