CI

At a glance

ClinicalIndex Comparison Record
Phase 1Enrolling by Invitation· 96 target
Drug / intervention
ND-003 tablets +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06169579
NCT06169579Phase 1Enrolling by InvitationUpdate OverdueUpdated 19mo ago · Completion was 6mo ago
Enrollment Stalled

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.

Shenzhen NewDEL Biotech, Co., Ltd·interventional·Posted Dec 13, 2023·Updated Nov 15, 2024

In Brief

A Phase 1 clinical trial evaluating ND-003 tablets for Advanced Solid Tumor. Currently enrolling by invitation, targeting 96 participants across 21 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 1Enrolling by InvitationOverdue
202420252026
First PostedDec 13, 2023
Enrollment StartFeb 4, 2024
Primary CompletionDec 1, 2025
Study CompletionJun 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 2.6 years ago

Interventions

ND-003 tabletsdrug

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

ND-003 tabletsdrug

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

ND-003 tabletsdrug

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

ND-003 tabletsdrug

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

ND-003 tabletsdrug

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

ND-003 tabletsdrug

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

ND-003 tabletsdrug

ND-003 tablets will be administered orally over continuous 28-days cycles.

ND-003 tabletsdrug

ND-003 tablets will be administered orally over continuous 28-days cycles.