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
Sarah Cannon Research Institute 335 24th Avenue North, Suite 400
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
SCRI Patient Intake Team
SCRI Patient Intake Team
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
START San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
START Mountain
West Valley City, Utah 84119
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.