Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer
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ClinicalTrials.gov Identifier: NCT03884517 |
Recruitment Status : Unknown
Verified March 2019 by Bio-Thera Solutions.
Recruitment status was: Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Cancer | Drug: BAT8003 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open, Escalating Phase I Clinical Trial of BAT8003 (for Injection) on the Safety, Tolerability and Pharmacokinetics for Patients With Advanced Epithelial Cancer |
Actual Study Start Date : | March 15, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: BAT8003 0.2mg/kg
BAT8003,0.2mg/kg,intravenous infusion, sample size 1-3
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Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 0.5mg/kg
BAT8003,0.5mg/kg,intravenous infusion, sample size 1-3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 1mg/kg
BAT8003,1mg/kg,intravenous infusion, sample size 3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 2mg/kg
BAT8003,2mg/kg,intravenous infusion, sample size 3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 4mg/kg
BAT8003,4mg/kg,intravenous infusion, sample size 3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 6mg/kg
BAT8003,6mg/kg,intravenous infusion, sample size 3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 8mg/kg
BAT8003,8mg/kg,intravenous infusion, sample size 3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: BAT8003 10mg/kg
BAT8003,10mg/kg,intravenous infusion, sample size 3
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
Experimental: Amplification group
BAT8003,intravenous infusion,choose one proper dose from 0.2、0.5、1、2、4、6、8、10mg/kg
|
Drug: BAT8003
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
- dose-limiting toxicity (DLT) [ Time Frame: 3weeks ]safety and tolerability endpoint
- maximum tolerated dose (MTD) [ Time Frame: 3weeks ]safety and tolerability endpoint
- Area under the curve(AUC) [ Time Frame: no more than 24weeks ]pharmacokinetic endpoint
- Maximum serum drug concentration(Cmax) [ Time Frame: no more than 24weeks ]pharmacokinetic endpoint
- half-life period(t1/2) [ Time Frame: no more than 24weeks ]pharmacokinetic endpoint
- Maximum serum drug time(Tmax) [ Time Frame: no more than 24weeks ]pharmacokinetic endpoint

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient or his legal representative signs the informed consent form and fully understands the content, process of the study and possible adverse reactions of the study, and is willing to follow up and image evaluation according to the time specified in the protocol.
- Age 18-75 years old (including boundary value), gender is not limited;
- advanced epithelial cancer who are ineffective, unable to receive, or absent from standard treatment, histologically or cytologically confirmed;
- positive Trop2 expression;
- At least one measurable tumor lesions according to RECIST 1.1(Evaluation Standard for Solid Tumor Efficacy 1.1);
- The US Eastern Cooperative Oncology Group (ECOG) scores 0 to 1;
- Expected survival period ≥ 3 months;
- proper Laboratory test indicators:
- Echocardiographic examination of left ventricular ejection fraction (LVEF) ≥ 50%;
- The treatment for solid cancer has been completed for at least 3 weeks, and has basically recovered from the adverse reactions of previous treatment (≤1 grade according to CTCAE5.0(Common Terminology Criteria for Adverse Events 5.0) standard, except for hair loss);
Exclusion Criteria:
- Have active hepatitis B (HBV) or hepatitis C (HCV) or syphilis;
- History of immunodeficiency;
- Other active infections of clinical significance, based on investigator's judgment;
- other concurrent, severe, or uncontrollable systemic diseases ;
- History of moderate or severe dyspnea due to advanced malignancy or its complications or severe pulmonary primary disease, or the need for continuous oxygen therapy, or current interstitial lung disease (ILD) Or pneumonia;
- clinically significant Cardiovascular abnormalities according to any of the following definitions within 6 months prior to enrollment;
- The brain or other central nervous system metastasis symptom;;
- There are ≥ 2 grade peripheral neuropathy according to CTCAE5.0(Common Terminology Criteria for Adverse Events 5.0);
- Participated in and received other clinical trials within 4 weeks prior to enrollment;
- Major surgical treatment within 4 weeks;
- Used of strong CYP3A4 inhibitors and have not undergone circulatory clearance (less than 3 elimination half-lives) prior to administration of the first clinical study drug;
- Known allergy to the test drug component, or it is suspected that it may be allergic;
- Pregnant or lactating women;
- Alcohol abuse, drug abuse or history of drug abuse in the past 6 months;
- The investigator believes the patient is not suitable for this trail because of other reasons.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884517
Contact: qiang wei | 86-20-32203220 | qwei@bio-thera.com |
China, Zhejiang | |
The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting |
Hangzhou, Zhejiang, China | |
Contact: jian huang hjys@zju.edu.cn |
Principal Investigator: | jian huang | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Responsible Party: | Bio-Thera Solutions |
ClinicalTrials.gov Identifier: | NCT03884517 |
Other Study ID Numbers: |
BAT-8003-001-CR |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | March 21, 2019 |
Last Verified: | March 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |