SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies f
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors
| Condition(s) | Solid Tumor, Gastric Cancer, Liver Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors |
| Who can participate | Inclusion Criteria: 1. Male or female participants aged 18 to 75 years (inclusive). 2. For Phase Ia: Participants with histologic diagnosis and confirmed solid tumor; For Phase Ib: Participants with one of the two tumor types: Group 1: advanced primary liver cancer; Group 2: Advanced primary gastric cancer (including gastroesophageal junction adenocarcinoma). 3. There must be at least one measurable lesion defined by RECIST v1.1. Lesions intended for biopsy should generally not be selected as target lesions, unless the investigator assesses that the biopsy of the lesion will not affect subsequent tumor evaluations. Lesions that have previously undergone radiation therapy, interventional therapy, or other local treatments should generally not be selected as target lesions, unless the lesion |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Qurgen Inc. |
| Locations | Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China (+5 more sites) |
| Start date | 2025-02-26 |
| NCT ID | NCT06873659 |
| Official listing | https://clinicaltrials.gov/study/NCT06873659 |