DXP-106 in Solid Tumor Patients.
The goal of this clinical trial is to evaluate the safety and tolerability of DXP-106 in Chinese patients with advanced solid tumors. The main questions it aims to answer are: For Part I: 1. The safety and tolerability of DXP-106 monotherapy in patients with advanced solid tumors; 2. The dose-limiting toxicities (DLTs)
| Condition(s) | Solid Tumor, Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to evaluate the safety and tolerability of DXP-106 in Chinese patients with advanced solid tumors. The main questions it aims to answer are: For Part I: 1. The safety and tolerability of DXP-106 monotherapy in patients with advanced solid tumors; 2. The dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D); 3. The pharmacokinetics (PK) profile, the immunogenicity of DXP-106 following administration in patients with advanced solid tumors; 4. The preliminary efficacy of DXP-106 in patients with advanced solid tumors; 5. The pharmacodynamic (PD) profiles of DXP-106 following administration in patients with advanced solid tumors as exploratory objective; For Part2: 1. The safety and tolerabi |
| Who can participate | Inclusion criteria: * Participants who fully understand the trial objectives, nature, procedures, and potential adverse reactions, and who voluntarily agree to participate in the study and provide signed informed consent. * Patients aged 18 to 75 years (inclusive, based on the date of signing the informed consent form), both male and female. * Measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST criteria within 4 weeks prior to screening. * Study Population * Part 1: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are ineligible for surgery or curative radiotherapy and have experienced disease progression after standard treatment or are intolerant to such therapy. Target tumor types |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Singlomics Biopharmaceuticals Zhuhai Co., Ltd. |
| Locations | Harbin, Heilongjiang, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China |
| Start date | 2026-03-23 |
| NCT ID | NCT07532018 |
| Official listing | https://clinicaltrials.gov/study/NCT07532018 |