Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169579
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-21
First Post:
2023-11-23
Brief Title:
An Open-label Phase 1 Study to Determine the Maximum Tolerated Dose of ND-003 in Patients With Advanced Solid Cancers
Sponsor:
Shenzhen NewDEL Biotech Co Ltd
Organization:
Shenzhen NewDEL Biotech Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None