Study in Advanced Solid Tumor Patients
Purpose
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.
Condition
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Phase 1: no randomization will be performed. Phase 2: participants in each cohort will be randomized with a 1:1 ratio to receive one of the expansion doses of CLIO-8221.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- No, this is an open-label trial
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Nashville, Tennessee 37203
SCRI Patient Intake Team
Houston, Texas 77030
San Antonio, Texas 78229
West Valley City, Utah 84119
More Details
- Status
- Recruiting
- Sponsor
- Callio Therapeutics
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.