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NCT07300943PHASE1, PHASE2Recruiting

Study in Advanced Solid Tumor Patients

Callio Therapeutics

Start Date

3/19/2026

Completion Date

7/17/2028

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.

Detailed Description

Phase 1: Dose-escalation and Dose Level Expansion. Dose escalation safety data will be reviewed by a Safety Monitoring Committee (SMC) to guide dosing decisions. Backfill enrollment may be used to further characterize safety, PK/PD, and antitumor activity. 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. Safety, tolerability, PK/PD, and response data will support selection of the recommended Phase 2 dose (RP2D) for further development.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

CLIO-8221

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Conditions

Advanced Solid Tumor

Locations

DFCI

Boston, Massachusetts 02215-5450

United States

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

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

START San Antonio

San Antonio, Texas 78229

United States

START Mountain

West Valley City, Utah 84119

United States

Scientia Clinical Research

Randwick, New South Wales 2031

Australia

Integrated Clinical Oncology Network Pty Ltd

South Brisbane, Queensland 4101

Australia

Peter Maccallum Cancer Centre

Box Hill, Victoria 3128

Australia

AlfredHealth

Heidelberg, Victoria 3084

Australia

Royal Melbourne Hospital

Melbourne, Victoria 3052

Australia

Linear Clinical Research Ltd

Nedlands, Western Australia 6009

Australia