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

• ClinicalTrials.gov Identifier: NCT03884517
• Recruitment Status: Unknown
• First Posted: March 21, 2019
• Last Update Posted: March 21, 2019
• Sponsor: Bio-Thera Solutions
• Information provided by (Responsible Party): Bio-Thera Solutions

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: jian huang; Second Affiliated Hospital, School of Medicine, Zhejiang University

More Information

• Responsible Party: Bio-Thera Solutions
• ClinicalTrials.gov Identifier: NCT03884517
• Other Study ID Numbers: BAT-8003-001-CR
• First Posted: March 21, 2019
• 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