A Study of HLX42 in Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
| Condition(s) | Solid Tumor and NSCLC |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42. |
| Who can participate | Inclusion Criteria: 1. ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female; 2. Patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 1); Patients with histologically or cytologically confirmed advanced/metastatic malignant NSCLC, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 2); 3. At least one measurable lesion as per RECIST 1.1； 4. An ECOG performance status score of 0-1； 5. Life expectancy \> 3 months; 6. Adequate organ functions as confirmed by laboratory tests within 7 days prior to the first administration of the investigational produc |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Henlius Biotech |
| Locations | Guangdong, Guangzhou, China |
| Start date | 2024-03-14 |
| NCT ID | NCT06210815 |
| Official listing | https://clinicaltrials.gov/study/NCT06210815 |