CLIO-8221 treatment for advanced solid tumors
A Phase 1/2 Study of CLIO-8221 in Patients With Advanced Solid Tumors
This trial tests CLIO-8221 in adults with metastatic or unresectable advanced solid tumors to find a safe dose and see if it can shrink tumors or slow disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 306 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Callio Therapeutics Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 11 sites (Boston, Massachusetts and 10 other locations) |
| Trial ID | NCT07300943 on ClinicalTrials.gov |
What this trial studies
This multicenter Phase 1/2 trial begins with dose-escalation and expansion cohorts to determine the maximum tolerated dose and/or recommended dose for expansion, with dosing decisions guided by a Safety Monitoring Committee. Backfill enrollment and PK/PD sampling will be used to further characterize safety, tolerability, and pharmacology. Phase 2 consists of tumor-specific expansion cohorts to optimize dosing and gather preliminary evidence of antitumor activity. Data on safety, PK/PD, and tumor response will support selection of a recommended Phase 2 dose for later development.
Who should consider this trial
Good fit: Adults with metastatic or unresectable solid tumors who have measurable disease per RECIST 1.1, ECOG performance status 0–1, LVEF ≥50%, and prior appropriate therapies (unless ineligible or without access) are the intended participants.
Not a fit: Patients previously treated with an ATR inhibitor, those with competing active malignancies that interfere with assessment, or those with poor cardiac function or ECOG >1 are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, CLIO-8221 could provide a new treatment option that shrinks tumors or slows disease progression for some patients with advanced solid tumors.
How similar studies have performed: Early-phase studies of other ATR inhibitors have shown preliminary activity in selected tumors, particularly those with DNA-repair defects, but large confirmatory successes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Boston, Massachusetts and 10 other locations
- Dfci — Boston, Massachusetts, United States (Not_yet_recruiting)
- Sarah Cannon Research Institute 335 24th Avenue North, Suite 400 — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
- START Mountain — West Valley City, Utah, United States (Recruiting)
- Scientia Clinical Research — Randwick, New South Wales, Australia (Recruiting)
- Integrated Clinical Oncology Network Pty Ltd — South Brisbane, Queensland, Australia (Recruiting)
- Peter Maccallum Cancer Centre — Box Hill, Victoria, Australia (Recruiting)
- AlfredHealth — Heidelberg, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
- Linear Clinical Research Ltd — Nedlands, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Cmo
- Email: clinical@calliotx.com
- Phone: 206-602-3134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.