NCT06169579

An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of ND-003 in Patients With Advanced Solid Cancers

A Single-arm, Non-randomized, Open-label, Dose-escalation and Dose-expansion, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles, as Well as Preliminary Efficacy, of ND-003 in Chinese Patients With Advanced Solid Tumors.

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Shenzhen NewDEL Biotech, Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial will be conducted in 2 parts: an initial dose escalation phase of drug ND-003 tablets in patients with solid tumors will be followed by an expansion phase in subjects with solid tumors harboring NTRK or RET Fusion or Mutation. The objectives of the study are to determine the safety, tolerability, pharmacokinetic and pharmacodynamics profiles, as well as preliminary efficacy of orally administered ND-003 in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ND-003 tablets	ND-003 tablets will be administered orally and observe 4 days, and followed by over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally and observe 4 days, and followed by over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally and observe 4 days, and followed by over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally and observe 4 days, and followed by over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally and observe 4 days, and followed by over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally and observe 4 days, and followed by over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally over continuous 28-days cycles.
DRUG	ND-003 tablets	ND-003 tablets will be administered orally over continuous 28-days cycles.

Timeline

• Start date: 2024-02-04
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2023-12-13
• Last updated: 2024-11-15

Locations

21 sites across 1 country: China