NCT07230977 GenSci139 in Patients With Advanced Solid Tumors
| NCT ID | NCT07230977 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2028-07-07 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.
Eligibility Criteria
Inclusion Criteria: * Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci139 and any study procedures). * Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures. * Adult participants (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent. * Is able to provide tumor tissues. Fresh biopsy specimens or archival tumor tissue samples obtained after last treatment are strongly preferred, and if not available, providing other archival tumor tissue specimens or not may be enrolled after discussion with sponsor. * Has at least one measurable lesion by RECIST v1.1. * Has an eastern cancer collaboration group (ECOG) status of 0 or 1. * Left ventricular ejection fraction (LVEF) ≥50%. * Has a life expectancy of ≥ 3 months. * Has adequate hematologic and organ func