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Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients
Sponsor: Bio-Thera Solutions
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
Conditions
Interventions
BAT6021
Ⅳ infusions
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