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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/ Standard 3+3 2.1mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 2.1mg/kg, Frequency: once every 3 weeks, Duration: 1year |
|
| B/ Standard 3+3 2.4mg/kg of BAT8010 | Experimental | Drug: 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, Dosage: 2.7 mg/kg, Frequency: once every 3 weeks, Duration: 1year |
|
| Standard 3+3 15 mg/kg of BAT1006 | Experimental | Drug: BAT1006, Dosage: 15 mg/kg, Frequency: once every 3 weeks, Duration: 1year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT8010 for Injection | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | DLT events and their incidence. | The first administration cycle(21 days) |
| vital signs | Number of participants with abnormal vital signs | Through study completion, 1 year |
| Physical examination | Number of participants with abnormal physical examination | Through study completion, 1 year |
| Adverse events | Number of cases with all adverse medical events that occur after the subject receives the investigational drug | 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 | Through study completion, 1 year |
| Number of participants with abnormal clinical auxiliary tests | Clinical auxiliary tests | 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 | Through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic | Level of Cmax | 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 |
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Inclusion Criteria:
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);
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xizhen Hu | Contact | 15802510972 | xzhu@bio-thera.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu | Medical Ethics Committee of Sun Yat-sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| BAT1006 for Injection | Drug | Intravenous |
|
| 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) | Through study completion, 1 year |
Level of Tmax |
| 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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