drugset / Trial / NCT06169579
An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of ND-003 in Patients With Advanced Solid Cancers
Phase 1
Enrolling by invitation
96 enrolled
Shenzhen NewDEL Biotech, Co., Ltd
Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd. · collabSun Yat-sen University · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is done to test the safety and preliminary efficacy of drug ND-003 tablets in patients with solid tumors. ND-003 is a highly potent and selective small molecular inhibitor of NTRK (neurotrophic receptor tyrosine kinase) and RET (rearranged during transfection). The study also investigates how the drug is absorbed and processed in the human body.
Timeline
- Start
- 2024-02-04
- Primary completion
- 2025-12
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ND-003 | Small molecule | 40 mg | Oral |
| Subject | ND-003 | Small molecule | 80 mg | Oral |
| Subject | ND-003 | Small molecule | 160 mg | Oral |
| Subject | ND-003 | Small molecule | 300 mg | Oral |
| Subject | ND-003 | Small molecule | 500 mg | Oral |
| Subject | ND-003 | Small molecule | 800 mg | Oral |