Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection
Study Details
Study Description
Brief Summary
Objectives: To evaluate the safety and tolerability of BAT8006 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8006 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A/1.2mg/kg Drug：BAT8006 for Injection, 1.2mg/kg |
Drug: BAT8006 for Injection
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
Other Names:
|
| Experimental: B/2.4mg/kg Drug：BAT8006 for Injection, 2.4mg/kg |
Drug: BAT8006 for Injection
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
Other Names:
|
| Experimental: C/ 3.5mg/kg Drug：BAT8006 for Injection, 3.5mg/kg |
Drug: BAT8006 for Injection
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
Other Names:
|
| Experimental: D/ 5.0mg/kg Drug：BAT8006 for Injection, 5.0mg/kg |
Drug: BAT8006 for Injection
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
Other Names:
|
| Experimental: E/ 6.5mg/kg Drug：BAT8006 for Injection, 6.5mg/kg |
Drug: BAT8006 for Injection
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
Other Names:
|
| Experimental: F/8.0mg/kg Drug：BAT8006 for Injection, 8.0mg/kg |
Drug: BAT8006 for Injection
Intravenous infusion, once every 3 weeks (Q3W), the recommended infusion time of the first cycle is ≥90 minutes, if no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Dose limiting toxicity (DLT) [At the end of Cycle 1 (each cycle is 21 days)]
DLT refers to any grade 3 or higher toxicities associated with the test drug that occurred within 21 days of the subject's initial administration
- Maximum tolerated dose (MTD) [At the end of Cycle 1 (each cycle is 21 days)]
MTD was defined as exploration in a dose group observed ≤1/6 of subjects during the DLT evaluation period to the highest dose level of DLT.
Secondary Outcome Measures
- Pharmacokinetics（PK） [The first 6 treatment cycles(each cycle is 21 days)]
Cmax
Eligibility Criteria
Criteria
Inclusion Criteria:
- The following items can be included in the study:
-
Age from 18 to 75 (including boundary value), no gender limitation;
-
Voluntarily sign informed consent;
-
Patients must be histologically or cytologically confirmed with advanced or metastatic solid tumors that have failed or have no effective standard therapy, are intolerant to standard therapy or refuse standard therapy, depending on the type of tumor, at the discretion of the clinician;
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Presence of at least one measurable tumor lesion according to RECIST1.1 criteria;
-
ECOG (Eastern Oncology Collaboration group) physical status score requires 0 or 1;
-
The researchers assessed the expected survival ≥12 weeks;
-
have enough organ and bone marrow reserve function;
Exclusion Criteria:
- If you meet any of the following conditions, you will not be allowed to enter this test:
-
Have received experimental drug treatment or participated in clinical study of medical devices within 4 weeks before the first study drug was given;
-
Other antitumor treatments, such as chemotherapy, radiotherapy (palliative radiotherapy should be completed within 2 weeks before the first drug administration), targeted therapy, immunotherapy (interval of at least 4 weeks or at least 5 half-lives, whichever is longer), hormone therapy (except alternative therapy) within 4 weeks before the first drug administration;
-
Have received anti-tumor traditional Chinese medicine, proprietary Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks prior to the first administration of study drugs;
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Before the first administration of the study drug, there were still patients with AE (CTCAE5.0) caused by previous antitumor therapy > grade 1, except for the following: a. Hair loss. B. Pigmentation; C. The distal toxicity caused by chemotherapy and radiotherapy cannot be further recovered;
-
Patients who have undergone major surgery or have not recovered after surgery, or have suffered significant trauma within 4 weeks prior to the first administration of the study drug, or need to undergo elective surgery during the study period;
-
Those with a history of allogeneic cell or solid organ transplantation;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of Jilin University | Changchun | Jilin | China |
Sponsors and Collaborators
- Bio-Thera Solutions
Investigators
- Principal Investigator: Yanhua Ding, The First Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BAT-8006-001-CR