Advanced or Metastatic Solid TumorsPhase 1NCT05848466
Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients
A Phase 1 study testing BAT8010 for Injection in people with Advanced or Metastatic Solid Tumors, run by Bio-Thera Solutions at 1 site in China.
Trial summary
The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- BAT8010 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2023to 6 Jun 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signing of informed consent.
- The expected survival period is more than 3 months base on the evaluation of the investigator.
- Eastern Cooperative Oncology Group (ECOG) should be 0-1.
- Patients who fail to standard treatment or have no standard treatment or are not suitable for standard treatment at this stage, and who have Human epidermal growth factor receptor-2 (HER2) expression (including Immunohistochemistry (IHC)3+, IHC2+/fluorescence in situ hybridization (FISH)+and IHC2+/FISH - patients) confirmed by histopathology and cytopathology, the dose escalation stage includes but is not limited to breast cancer, gastric cancer, non-small cell lung cancer, biliary tract cancer, colorectal cancer, urothelial cancer, etc., and the expansion stage only includes breast cancer.
- An evaluable tumor focus was necessary in the dose escalation stage, and at least one measurable tumor focus in the dose expanding stage (according to RECIST 1.1 standard).
- Enough organs, bone marrow reserve function and heart function.
- Must agree to take effective contraceptive methods to prevent pregnancy.
Who cannot join
- Previously received HER2 targeted drug therapy such as trastuzumab or pertuzumab, Trastuzumab Emtansine or Enhertu, and the treatment of topoisomerase I inhibitors (such as irinotecan), there were adverse event (AE) equal to or pass 3 levels that were determined to be treatment-related or drug related
- Before the first administration of the investigational drug, the AE (CTCAE5.0) caused by previous anti-tumor treatment was still higher than grade 1
- Primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or previous history of epilepsy. Patients with asymptomatic or symptomatic central nervous system metastasis who have achieved clinical control but are judged stable by the investigator can be included.
- Major surgery has been performed within 28 days before the first use of the study drug, or if it has been more than 21 days after surgery, but the postoperative complications are still continuing.
- Subjects who had severe infection within 4 weeks before the first administration, or had any symptoms and signs of active infection within 2 weeks before the first administration.
- Untreated or under treatment tuberculosis subjects, with a history of immune deficiency, or other immune deficiency diseases, or with a history of organ transplantation.
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- Active hepatitis B virus infected, hepatitis C virus infected, Treponema pallidum antibody positive and Rapid plasma reagin ring card test (RPR) positive.
- Patients with symptomatic congestive heart failure (New York Heart Association (NYHA) grade II to IV) or serious arrhythmia requiring treatment (QTc prolongation of 12-lead electrocardiogram (ECG) 450 ms [male], 470 ms [female]), and patients with myocardial infarction and unstable angina pectoris in the past 6 months. Except for atrial fibrillation or paroxysmal supraventricular tachycardia
- Patients who have a history of non-infectious pneumonia requiring glucocorticoid treatment or who currently have interstitial lung disease.
- There are any other serious potential diseases.
- Previous anti-tumor therapy (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) is less than 28 days from the first study administration.
- Therapeutic radiopharmaceuticals must be discontinued 8 weeks before the first study administration.
- Known allergy or intolerance to the study drug or its excipients.
- Pregnant or lactating women.
- The study participants who were considered unsuitable for the study by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT8010 for Injection in Patients With Advanced or Metastatic Solid Tumors
The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Participants will be given one of below dose once every three weeks: 0.8mg/kg, 1.2mg/kg, 2.4mg/kg, 3.6mg/kg, 4.8mg/kg, 6.0mg/kg, 7.2mg/kg, 8.4mg/kg. The dose escalation follow adopt accelerated titration and "3+3" dose increasing rule.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- BAT8010 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
| Study group | Role | What they receive |
|---|---|---|
| A/ Accelerated titration 0.8mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 0.8mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
| B/ Standard 3+3 1.2mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 1.2mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
| C/ 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 |
| D/ Standard 3+3 3.6mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 3.6mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
| E/ Standard 3+3 4.8mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 4.8mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
| F/ Standard 3+3 6.0mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 6.0mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
| G/ Standard 3+3 7.2mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 7.2mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
| H/ Standard 3+3 8.4mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 8.4mg/kg, Frequency: once every 3 weeks, Duration: 1year Receives: Drug: BAT8010 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Grade 5 toxicity; Hematological toxicity: Grade 4 alanine-aminotransferase(ALT) or aspartate-aminotransferase(AST) increase: AST or ALT>5 times upper limit of normal value(ULN), with ≥ 2 levels of blood bilirubin increase; Hematological toxicity: Grade 4 neutropenia lasting>7 days. ≥Grade 3 neutropenia with fever (single body temperature>38.3 or continuous body temperature ≥ 38 ℃, more than 1 Hour). Grade 4 anemia. Grade 4 thrombocytopenia. ≥ Grade 3 thrombocytopenia and lasting>7 days. ≥ Grade 3 thrombocytopenia with bleeding; Other ≥Grade 3 non hepatic toxicity, non hematological toxicity.
Measured: 3 weeks
maximum tolerated dose (MTD)
MTD was defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period
Measured: 3 weeks
Secondary outcomes (7)
Pharmacokinetic
Cmax
Measured: every cycle until 18 weeks (one cycle equals 3 weeks)]
Immunogenicity
Presence of anti drug antibody (ADA)/Neutralizing antibodies (NAb) ADA, Nab
Measured: every cycle until 18 weeks, every 4 cycles after 18 weeks (one cycle equals 3 weeks), up to 1 year
Objective response rate (ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and remained for a certain period of time, including CR and PR cases. Specifically divided into: 1.The ratio of patients with partial response (PR) or complete remission (CR) efficacy at the end of the first 6 cycles (18 weeks) of treatment. 2.The proportion of patients whose best response reached PR or CR during the entire study period.
Measured: through study completion, an average of 2 years
Duration of remission (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, an average of 2 years
Disease Control Rate (DCR)
The proportion of patients with reduced or stable tumors that remain for a certain period of time, including CR, PR, and Disease stability (SD) cases.
Measured: through study completion, an average of 2 years
Progression free survival (PFS)
The time from the first administration to the occurrence of objective tumor progression or all cause death
Measured: through study completion, an average of 2 years
Total survival period (OS)
The time from the date of first administration to the occurrence of death due to any cause. Subjects who were still alive at the time of analysis will use the date of their last contact as the deadline.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start10 Feb 2023
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chaohe Wang, Study director, Bio-Thera Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848466
- Sponsor's protocol ID
- BAT-8010-001-CR
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2023
- Last updated
- 30 Mar 2026
- Results posted
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT8010 for Injection in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05848466
- Acronym / sponsor ID
- BAT-8010-001-CR
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 8 May 2023 (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 goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Participants will be given one of below dose once every three weeks: 0.8mg/kg, 1.2mg/kg, 2.4mg/kg, 3.6mg/kg, 4.8mg/kg, 6.0mg/kg, 7.2mg/kg, 8.4mg/kg. The dose escalation follow adopt accelerated titration and "3+3" dose increasing rule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A/ Accelerated titration 0.8mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 0.8mg/kg, Frequency: once every 3 weeks, Duration: 1year |
| B/ Standard 3+3 1.2mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 1.2mg/kg, Frequency: once every 3 weeks, Duration: 1year |
| C/ 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 |
| D/ Standard 3+3 3.6mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 3.6mg/kg, Frequency: once every 3 weeks, Duration: 1year |
| E/ Standard 3+3 4.8mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 4.8mg/kg, Frequency: once every 3 weeks, Duration: 1year |
| F/ Standard 3+3 6.0mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 6.0mg/kg, Frequency: once every 3 weeks, Duration: 1year |
| G/ Standard 3+3 7.2mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 7.2mg/kg, Frequency: once every 3 weeks, Duration: 1year |
| H/ Standard 3+3 8.4mg/kg of BAT8010 | Experimental | Drug: BAT8010 for InjectionDrug: BAT8010, Dosage: 8.4mg/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 (7 listed)
- Voluntary signing of informed consent.
- The expected survival period is more than 3 months base on the evaluation of the investigator.
- Eastern Cooperative Oncology Group (ECOG) should be 0-1.
- Patients who fail to standard treatment or have no standard treatment or are not suitable for standard treatment at this stage, and who have Human epidermal growth factor receptor-2 (HER2) expression (including Immunohistochemistry (IHC)3+, IHC2+/fluorescence in situ hybridization (FISH)+and IHC2+/FISH - patients) confirmed by histopathology and cytopathology, the dose escalation stage includes but is not limited to breast cancer, gastric cancer, non-small cell lung cancer, biliary tract cancer, colorectal cancer, urothelial cancer, etc., and the expansion stage only includes breast cancer.
- An evaluable tumor focus was necessary in the dose escalation stage, and at least one measurable tumor focus in the dose expanding stage (according to RECIST 1.1 standard).
Key exclusion criteria (15 listed)
- Previously received HER2 targeted drug therapy such as trastuzumab or pertuzumab, Trastuzumab Emtansine or Enhertu, and the treatment of topoisomerase I inhibitors (such as irinotecan), there were adverse event (AE) equal to or pass 3 levels that were determined to be treatment-related or drug related
- Before the first administration of the investigational drug, the AE (CTCAE5.0) caused by previous anti-tumor treatment was still higher than grade 1
- Primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or previous history of epilepsy. Patients with asymptomatic or symptomatic central nervous system metastasis who have achieved clinical control but are judged stable by the investigator can be included.
- Major surgery has been performed within 28 days before the first use of the study drug, or if it has been more than 21 days after surgery, but the postoperative complications are still continuing.
- Subjects who had severe infection within 4 weeks before the first administration, or had any symptoms and signs of active infection within 2 weeks before the first administration.
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/ Accelerated titration 0.8mg/kg of BAT8010, B/ Standard 3+3 1.2mg/kg of BAT8010, C/ Standard 3+3 2.4mg/kg of BAT8010, D/ Standard 3+3 3.6mg/kg of BAT8010, E/ Standard 3+3 4.8mg/kg of BAT8010, F/ Standard 3+3 6.0mg/kg of BAT8010, G/ Standard 3+3 7.2mg/kg of BAT8010, H/ Standard 3+3 8.4mg/kg of BAT8010 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 3 weeks
Grade 5 toxicity; Hematological toxicity: Grade 4 alanine-aminotransferase(ALT) or aspartate-aminotransferase(AST) increase: AST or ALT>5 times upper limit of normal value(ULN), with ≥ 2 levels of blood bilirubin increase; Hematological toxicity: Grade 4 neutropenia lasting>7 days. ≥Grade 3 neutropenia with fever (single body temperature>38.3 or continuous body temperature ≥ 38 ℃, more than 1 Hour). Grade 4 anemia. Grade 4 thrombocytopenia. ≥ Grade 3 thrombocytopenia and lasting>7 days. ≥ Grade 3 thrombocytopenia with bleeding; Other ≥Grade 3 non hepatic toxicity, non hematological toxicity.
maximum tolerated dose (MTD)
Time frame: 3 weeks
MTD was defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period
7 secondary outcomes
Pharmacokinetic
Time frame: every cycle until 18 weeks (one cycle equals 3 weeks)]
Immunogenicity
Time frame: every cycle until 18 weeks, every 4 cycles after 18 weeks (one cycle equals 3 weeks), up to 1 year
Objective response rate (ORR)
Time frame: through study completion, an average of 2 years
Duration of remission (DoR)
Time frame: Through study completion, an average of 2 years
Disease Control Rate (DCR)
Time frame: through study completion, an average of 2 years
Progression free survival (PFS)
Time frame: through study completion, an average of 2 years
Total survival period (OS)
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaohe Wang study director
Bio-Thera Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAT8010 for Injection in people with Advanced or Metastatic 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 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 weeks). The study lists 2 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 30 Mar 2026.