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Study in Advanced Solid Tumor Patients
Sponsor: Callio Therapeutics
Summary
The study will be conducted in 2 phases: Phase 1: Dose-escalation and Dose Level Expansion, Phase 1 will determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). Phase 2: Tumor-Specific Expansions with Dose Optimization, Phase 2 will further evaluate CLIO-8221 in tumor-specific expansion cohorts to optimize dosing and assess preliminary efficacy.
Official title: A Phase 1/2 Study of CLIO-8221 in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
306
Start Date
2026-03-19
Completion Date
2028-07-17
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
CLIO-8221
intravenous (IV) infusion
Locations (11)
DFCI
Boston, Massachusetts, United States
Sarah Cannon Research Institute 335 24th Avenue North, Suite 400
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
START San Antonio
San Antonio, Texas, United States
START Mountain
West Valley City, Utah, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Integrated Clinical Oncology Network Pty Ltd
South Brisbane, Queensland, Australia
Peter Maccallum Cancer Centre
Box Hill, Victoria, Australia
AlfredHealth
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia