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Study of CLIO-8221 for Advanced Solid Tumors

This study is testing a new treatment called CLIO-8221, given through an IV (intravenous) infusion, for people with advanced solid tumors. These are cancers that have spread or cannot be removed by surgery, and you would have already tried other treatments. The main goals of this study are to understand the side effects of CLIO-8221, how safe it is, and to find the best dose. The study is open to adults aged 18 and older. It will first look at different doses to find the safest and most effective amount, and then further evaluate the treatment in specific types of tumors to see how well it works.

Study design
This is an interventional study with a planned enrollment of 306 participants. It has two phases: a dose-escalation phase to find the right dose, followed by a phase to further evaluate the treatment in specific tumor types.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be monitored for side effects and laboratory changes through the end of treatment, which could be up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07300943

Study in Advanced Solid Tumor Patients

Recruiting
PHASE1Ages 18+InterventionalTreatment
Callio Therapeutics
~306 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:CLIO-8221

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Type, incidence, severity, and seriousness of adverse events (AEs)
Measured over Through end of treatment, up to approximately 2 years.
+2 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT07300943

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AlfredHealth

    Heidelberg, Victoria, Australiastudy coordinator listed

    Recruiting

  • Integrated Clinical Oncology Network Pty Ltd

    South Brisbane, Queensland, Australiastudy coordinator listed

    Recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, Australiastudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Peter Maccallum Cancer Centre

    Box Hill, Victoria, Australiastudy coordinator listed

    Recruiting

  • Royal Melbourne Hospital

    Melbourne, Victoria, Australiastudy coordinator listed

    Recruiting

  • Sarah Cannon Research Institute 335 24th Avenue North, Suite 400

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • Scientia Clinical Research

    Randwick, New South Wales, Australiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

CMO
[email protected]
206-602-3134
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Type, incidence, severity, and seriousness of adverse events (AEs)Through end of treatment, up to approximately 2 years.

    Type, incidence, severity, and seriousness of AEs occurred

  • Type, incidence, and severity of laboratory abnormalitiesThrough end of treatment, up to approximately 2 years.

    Type, incidence, and severity of laboratory abnormalities occurred

  • Incidence of dose limiting toxicities dose (RP2D) of CLIO-8221From first dose through study day 21.

    Incidence of dose limiting toxicities occurred