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

NCT03884517 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-05-01

No results posted yet for this study

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.

Conditions

  • Advanced Solid Cancer

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • jian huang · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2021-02-08
Completion
2021-02-08

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884517 on ClinicalTrials.gov