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Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China

NCT05105971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-08

No results posted yet for this study

Summary

the main purpose:

* Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability
* Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules.

Secondary purpose:

* Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug;
* Evaluate the immunogenicity of BAT6026 injection;
* Evaluate the pharmacodynamic properties of BAT6026 injection;
* Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.

Conditions

Interventions

DRUG

BAT6026

Phase 1 dose titration study from BAT6026 0.01mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result

Sponsors & Collaborators

Principal Investigators

  • Li Zhang, M.D, Ph.D · Sun Yat-sen 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
2021-12-23
Primary Completion
2023-11-14
Completion
2023-11-14

Countries

  • China

Study Locations

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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 NCT05105971 on ClinicalTrials.gov