SG1906 for CLDN18.2-Positive Solid Tumors
This is a Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
| Condition(s) | Locally Advanced Unresectable or Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors. |
| Who can participate | Inclusion Criteria: * Patients must meet all the following criteria to be eligible for participation in this study: 1. Understand and voluntarily sign the informed consent form (ICF). 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 4. Expected survival time of ≥3 months. 5. Able to provide tumor tissue samples for CLDN18.2 detection. 6. Specific requirements for patients enrolled in Phase Ia and Phase Ib are as follows: Phase Ia Dose Escalation Phase 1. Patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor who have relapsed after standard therapy, have failed standard therapy, are intolerant to standard therapy, are not eligible for standard therapy, or refuse stan |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hangzhou Sumgen Biotech Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Shenyang, Liaoning, China; Shenyang, Liaoning, China (+3 more sites) |
| Start date | 2023-05-30 |
| NCT ID | NCT05857332 |
| Official listing | https://clinicaltrials.gov/study/NCT05857332 |