Recruiting
Phase 1
Phase 2

CLIO-8221

Sponsor:

Callio Therapeutics

Code:

NCT07300943

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CLIO-8221

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Study ID

NCT07300943

Start date

Mar 19, 2026

Status verified date

Apr, 2026

Completion date

Jul 17, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

306 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation and dose level expansion

Phase 1: CLIO-8221 monotherapy in escalating doses. Phase 2: Phase 2 will be initiated in tumor-specific expansion cohorts at selected doses.

Interventions

CLIO-8221

intravenous (IV) infusion

Primary outcome measure

  • Type, incidence, severity, and seriousness of adverse events (AEs) [ Time Frame: Through end of treatment, up to approximately 2 years. ]
  • Type, incidence, and severity of laboratory abnormalities [ Time Frame: Through end of treatment, up to approximately 2 years. ]
  • Incidence of dose limiting toxicities dose (RP2D) of CLIO-8221 [ Time Frame: From first dose through study day 21. ]

Central Contacts and Locations

Central contacts

CMO

206-602-3134clinical@calliotx.com

Locations

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

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

615-329-7640SCRINewPatient@USONCOLOGY.com

Principal Investigator:

Dr. Hamilton (Erika Paige Hamilton)

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Desirae Dufner, Dr

713-745-7813ddufner@mdanderson.org

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

START Mountain

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Callio Therapeutics

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Callio Therapeutics on 2026-05-01.