A Phase 1/2 Study of CLIO-8221 in Patients with Advanced Solid Tumors (NCT07300943)

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. 

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Malaka Ameratunga

Key inclusion data

Patients with advanced solid tumors. Patients must have metastatic or unresectable disease not suitable for further local treatment and should have received prior beneficial therapies unless ineligible, unwilling, or lacking access. Must have had no prior anti-tumor treatment with an ATRi. No known active central nervous system metastases or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, they have no new or enlarging brain metastases, and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to Cycle 1 Day 1. Must have no history of (non-infectious) ILD/pneumonitis ≥ Grade 2 (or that required steroids, if grading is not available) within the past 12 months, has current ILD/pneumonitis, or where ILD/pneumonitis is clinically suspected and  cannot be ruled out by imaging at screening.