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A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors

NCT06172309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-29

No results posted yet for this study

Summary

This is an open-label, single-arm, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors.

The study comprises a dose-escalation phase and a dose-expansion phase.

1. Dose-escalation:using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of NTQ1062 at 20, 50, 100, 200, 300, 400 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD).
2. Dose-expansion:the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors, and to identify the recommended phase 2 dose (RP2D).

Conditions

Interventions

DRUG

NTQ1062

tablet(s) PO

Sponsors & Collaborators

  • Nanjing Chia-tai Tianqing Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2024-04-20
Completion
2024-05-27

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06172309 on ClinicalTrials.gov