Study in Advanced Solid Tumor Patients
Start Date
3/19/2026
Completion Date
7/17/2028
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.
Detailed Description
Phase 1: Dose-escalation and Dose Level Expansion. Dose escalation safety data will be reviewed by a Safety Monitoring Committee (SMC) to guide dosing decisions. Backfill enrollment may be used to further characterize safety, PK/PD, and antitumor activity. 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. Safety, tolerability, PK/PD, and response data will support selection of the recommended Phase 2 dose (RP2D) for further development.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CLIO-8221
Conditions
Locations
DFCI
Boston, Massachusetts 02215-5450
United States
Sarah Cannon Research Institute 335 24th Avenue North, Suite 400
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
START San Antonio
San Antonio, Texas 78229
United States
START Mountain
West Valley City, Utah 84119
United States
Scientia Clinical Research
Randwick, New South Wales 2031
Australia
Integrated Clinical Oncology Network Pty Ltd
South Brisbane, Queensland 4101
Australia
Peter Maccallum Cancer Centre
Box Hill, Victoria 3128
Australia
AlfredHealth
Heidelberg, Victoria 3084
Australia
Royal Melbourne Hospital
Melbourne, Victoria 3052
Australia
Linear Clinical Research Ltd
Nedlands, Western Australia 6009
Australia