MedTrace Logo

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China

NCT05120375 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-10-11

No results posted yet for this study

Summary

Main purpose:

* To evaluate the safety and tolerability of BAT6021 injection in the treatment of locally advanced or metastatic solid tumors with single drug or combined with tislelizumab(anti PD-1 monoclonal antibody);
* Explore the maximum tolerated dose (MTD) or maximum dosing dose (MAD) of BAT6021 injection monotherapy or in combination with tislelizumab and provide recommended dose and reasonable dosing regimen for phase II or subsequent clinical studies.

Secondary purpose:

* To evaluate the pharmacokinetic (PK) characteristics of BAT6021 injection with single or multiple doses of tislelizumab in patients with locally advanced or metastatic solid tumors;
* Evaluate the immunogenicity of BAT6021 injection;
* To evaluate the pharmacodynamics of BAT6021 injection;
* Preliminary evaluation of the anti-tumor efficacy of BAT6021 injection alone or in combination with tislelizumab.

Conditions

Interventions

DRUG

BAT6021

Ⅳ infusions

Sponsors & Collaborators

Principal Investigators

  • Yilong Wu, M.D, Ph.D · Guangdong Provincial People's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2023-04-07
Completion
2023-04-07

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
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 NCT05120375 on ClinicalTrials.gov