NCT07300943 Study in Advanced Solid Tumor Patients
| NCT ID | NCT07300943 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Callio Therapeutics |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 306 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 306 participants in total. It began in 2026-03-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07300943 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07300943 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07300943 currently recruiting?
Yes, NCT07300943 is actively recruiting participants. Contact the research team at clinical@calliotx.com for enrollment information.
Where is the NCT07300943 trial being conducted?
This trial is being conducted at Boston, United States, Nashville, United States, Houston, United States, San Antonio, United States and 7 additional locations.
Who is sponsoring the NCT07300943 clinical trial?
NCT07300943 is sponsored by Callio Therapeutics. The trial plans to enroll 306 participants.