Actively Recruiting
Study in Advanced Solid Tumor Patients
Led by Callio Therapeutics · Updated on 2026-05-01
306
Participants Needed
11
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study in Advanced Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Left ventricular ejection fraction (LVEF) 50% or higher by echocardiogram or multigated acquisition scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease based on RECIST version 1.1 at baseline
You will not qualify if you...
- Prior anti-tumor treatment with an ATR inhibitor (ATRi)
- Prior or concurrent malignancies that could interfere with safety or efficacy assessment, except for certain low-risk cancers like treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, and Stage I uterine cancer
- History of uncontrolled seizure disorders or significant neurodegenerative disorders including progressive peripheral neuropathy; stable Grade 2 or lower peripheral neuropathy allowed
- Clinically significant autoimmune disease currently or within the past 2 years, including need for systemic immunosuppressive therapy equivalent to more than 10 mg prednisone daily (local immunosuppressive therapy allowed)
- Any uncontrolled Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to treatment start
- History of hepatic cirrhosis, autoimmune hepatitis, or drug-associated hepatitis within the past 12 months
- Uncontrolled diabetes mellitus defined as hemoglobin A1c 8% or higher, or 7% to less than 8% with diabetes symptoms not otherwise explained
- Any other medical, social, or psychosocial factors that could affect safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
DFCI
Boston, Massachusetts, United States, 02215-5450
Not Yet Recruiting
2
Sarah Cannon Research Institute 335 24th Avenue North, Suite 400
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
5
START Mountain
West Valley City, Utah, United States, 84119
Actively Recruiting
6
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
7
Integrated Clinical Oncology Network Pty Ltd
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
8
Peter Maccallum Cancer Centre
Box Hill, Victoria, Australia, 3128
Actively Recruiting
9
AlfredHealth
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
10
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3052
Actively Recruiting
11
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
C
CMO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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