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

NCT06169579 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-11-15

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

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.

Sponsors & Collaborators

  • Shenzhen NewDEL Biotech, Co., Ltd

    lead INDUSTRY

  • Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.

    collaborator UNKNOWN

  • Sun Yat-sen University

    collaborator OTHER

Principal Investigators

  • Li Zhang, PhD · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-04
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169579 on ClinicalTrials.gov