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Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884517
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bio-Thera Solutions

Brief Summary:
The trial is divided into three periods. Dosing will be the first day of each cycle, 21 days per cycle. The first period is the day of first study drug delivery until the 21st day, that is, the first treatment cycle. The DLT observation, exploration of MTD, safety of single administration, tolerance and pharmacokinetics, immunity Original research will happen during this period. The second period is a 2-8 dosing cycle, with multiple doses of tolerance, pharmacokinetics, immunogenicity studies, and preliminary efficacy evaluations. After a 2-4 cycle study, patients with good tolerance and no tumor progression will continue to the 5-8 cycle dosing study. The third period is to expand the study. After exploring the MTD, the investigator and the sponsor can discuss to extend another 10-30 cases in a safe and effective dose group to further study the effectiveness and safety of BAT8003 and its pharmacokinetics.

Condition or disease Intervention/treatment Phase
Advanced Solid Cancer Drug: BAT8003 Phase 1

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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
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




Primary Outcome Measures :
  1. dose-limiting toxicity (DLT) [ Time Frame: 3weeks ]
    safety and tolerability endpoint

  2. maximum tolerated dose (MTD) [ Time Frame: 3weeks ]
    safety and tolerability endpoint

  3. Area under the curve(AUC) [ Time Frame: no more than 24weeks ]
    pharmacokinetic endpoint

  4. Maximum serum drug concentration(Cmax) [ Time Frame: no more than 24weeks ]
    pharmacokinetic endpoint

  5. half-life period(t1/2) [ Time Frame: no more than 24weeks ]
    pharmacokinetic endpoint

  6. Maximum serum drug time(Tmax) [ Time Frame: no more than 24weeks ]
    pharmacokinetic endpoint



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age 18-75 years old (including boundary value), gender is not limited;
  3. advanced epithelial cancer who are ineffective, unable to receive, or absent from standard treatment, histologically or cytologically confirmed;
  4. positive Trop2 expression;
  5. At least one measurable tumor lesions according to RECIST 1.1(Evaluation Standard for Solid Tumor Efficacy 1.1);
  6. The US Eastern Cooperative Oncology Group (ECOG) scores 0 to 1;
  7. Expected survival period ≥ 3 months;
  8. proper Laboratory test indicators:
  9. Echocardiographic examination of left ventricular ejection fraction (LVEF) ≥ 50%;
  10. 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:

  1. Have active hepatitis B (HBV) or hepatitis C (HCV) or syphilis;
  2. History of immunodeficiency;
  3. Other active infections of clinical significance, based on investigator's judgment;
  4. other concurrent, severe, or uncontrollable systemic diseases ;
  5. 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;
  6. clinically significant Cardiovascular abnormalities according to any of the following definitions within 6 months prior to enrollment;
  7. The brain or other central nervous system metastasis symptom;;
  8. There are ≥ 2 grade peripheral neuropathy according to CTCAE5.0(Common Terminology Criteria for Adverse Events 5.0);
  9. Participated in and received other clinical trials within 4 weeks prior to enrollment;
  10. Major surgical treatment within 4 weeks;
  11. 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;
  12. Known allergy to the test drug component, or it is suspected that it may be allergic;
  13. Pregnant or lactating women;
  14. Alcohol abuse, drug abuse or history of drug abuse in the past 6 months;
  15. The investigator believes the patient is not suitable for this trail because of other reasons.

Information from the National Library of Medicine

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


Contacts
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Contact: qiang wei 86-20-32203220 qwei@bio-thera.com

Locations
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China, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: jian huang       hjys@zju.edu.cn   
Sponsors and Collaborators
Bio-Thera Solutions
Investigators
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Principal Investigator: jian huang Second Affiliated Hospital, School of Medicine, Zhejiang University
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No