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TERMINATED
NCT05073484
PHASE1

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

Sponsor: Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

This first-in-human open-label, multi center, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of BAT6021 alone or in combination with BAT1308 (an anti-PD-1 antibody) in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2021-10-29

Completion Date

2023-03-30

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

BAT6021

Ⅳ infusions

DRUG

BAT1308

Ⅳ infusions

Locations (3)

Liverpool Hospital

Liverpool, New South Wales, Australia

Macquarie University Hospital

Sydney, New South Wales, Australia

Cabrini Hospital Malvern

Melbourne, Victoria, Australia