🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-05-01)

Study in Advanced Solid Tumor Patients

🟢 Recruiting Phase 1 💊 Investigational Drug / Biologic Sponsor: Callio Therapeutics

🩺 Protocol 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.

Primary Research Facility: DFCI (Boston, Massachusetts)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Advanced Solid Tumor?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older?

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 11 Registered Participating Sites

📍 Primary Site Map

Site: DFCI — Boston, Massachusetts

📍 All Participating Trial Locations (11 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. DFCI — Boston, Massachusetts

2. Sarah Cannon Research Institute 335 24th Avenue North, Suite 400 — Nashville, Tennessee • Contact: (615) 329-7640

3. MD Anderson Cancer Center — Houston, Texas • Contact: (713) 745-7813

4. START San Antonio — San Antonio, Texas

5. START Mountain — West Valley City, Utah

6. Scientia Clinical Research — Randwick, New South Wales • Contact: (029) 382-5800

7. Integrated Clinical Oncology Network Pty Ltd — South Brisbane, Queensland • Contact: (073) 737-4500

8. Peter Maccallum Cancer Centre — Box Hill, Victoria • Contact: (038) 559-5000

9. AlfredHealth — Heidelberg, Victoria • Contact: (039) 076-3129

10. Royal Melbourne Hospital — Melbourne, Victoria • Contact: (038) 559-5000

11. Linear Clinical Research Ltd — Nedlands, Western Australia • Contact: (086) 382-5100

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07300943 • Last Synced: 2026-05-01

View on ClinicalTrials.gov ↗