Study of ESG406 in Adults With Solid Tumors
This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort
| Condition(s) | Locally Advanced/Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib. |
| Who can participate | Key Inclusion Criteria: * Males and females aged 18 to 80 years. * Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. * At least one measurable lesion per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥12 weeks. * Adequate organ and bone marrow function. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Key Exclusion Criteria: * Use of any cancer therapy (chemotherap |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Shanghai Escugen Biotechnology Co., Ltd |
| Locations | Chongqing, Chongqing Municipality, China; Xi’an, Shanxi, China; Hangzhou, Zhejiang, China |
| Start date | 2025-06-04 |
| NCT ID | NCT06979674 |
| Official listing | https://clinicaltrials.gov/study/NCT06979674 |