Study in Advanced Solid Tumor Patients

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT07300943

Run by

Callio Therapeutics

People needed

306

Starts

2026-03-19

Expected to finish

2028-07-17

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• LVEF ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Measurable disease per RECIST version 1.1 at baseline

You may not qualify if…

• Prior anti-tumor treatment with an ATRi.
• Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately 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 clinically significant neurodegenerative disorders, including progressive peripheral neuropathy. Stable Grade ≤ 2 peripheral neuropathy is allowed.
• Clinically significant autoimmune disease, either currently present or present within the previous 2 years, including a current requirement for systemic immunosuppressive therapy equivalent to >10 mg/prednisone daily (local immunosuppressive therapy such as inhaled or topical corticosteroids is allowed).
• Any uncontrolled Grade ≥ 3 (per NCI CTCAE version 6.0) viral, bacterial, or fungal infection within 2 weeks prior to Cycle 1 Day 1. Routine antimicrobial prophylaxis is permitted.
• History of hepatic cirrhosis, autoimmune hepatitis, or drug-associated hepatitis within the past 12 months.
• Uncontrolled diabetes mellitus, defined as Hgb A1c ≥8% or Hgb A1c between 7% and <8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
• Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
• Additional protocol defined inclusion/exclusion criteria may apply

Where it is running

• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia (enrolling)
• Sarah Cannon Research Institute 335 24th Avenue North, Suite 400 — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• START San Antonio — San Antonio, Texas, United States (enrolling)
• START Mountain — West Valley City, Utah, United States (enrolling)
• Scientia Clinical Research — Randwick, New South Wales, Australia (enrolling)
• Integrated Clinical Oncology Network Pty Ltd — South Brisbane, Queensland, Australia (enrolling)
• Peter Maccallum Cancer Centre — Box Hill, Victoria, Australia (enrolling)
• AlfredHealth — Heidelberg, Victoria, Australia (enrolling)
• Royal Melbourne Hospital — Melbourne, Victoria, Australia (enrolling)
• DFCI — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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