NCT07300943

Study in Advanced Solid Tumor Patients

A Phase 1/2 Study of CLIO-8221 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Callio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CLIO-8221	intravenous (IV) infusion

Timeline

• Start date: 2026-03-19
• Primary completion: 2027-12-31
• Completion: 2028-07-17
• First posted: 2025-12-24
• Last updated: 2026-03-25

Locations

11 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study