THE-0504 in Patients With Solid Tumors
Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.
| Condition(s) | Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Gastric Cancer (GC), Triple -Negative Breast Cancer, Pancreas Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors. |
| Who can participate | Inclusion Criteria: Patients will be enrolled in the study if they meet all the following criteria: 1. written informed consent obtained; 2. both gender adult (≥ 18 years) patients; 3. diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative Breast Cancer (TNBrCa); 4. measurable metastatic disease or locally advanced unresectable tumors; 5. have exhausted all EMA-approved treatment options; 6. ECOG Performance Status graded as 0 or 1; 7. patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Thena Biotech S.r.l. |
| Locations | Rome, Lazio, Italy |
| Start date | 2024-11-13 |
| NCT ID | NCT07646106 |
| Official listing | https://clinicaltrials.gov/study/NCT07646106 |