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To Evaluate the Efficacy of QLH11811 in Advanced NSCLC Patients With EGFR Mutation

NCT05555212 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-03-28

No results posted yet for this study

Summary

This is a phase 1, open-label, dose escalation and cohort expansion study and conducted in China and the United States to investigate the safety, tolerability and preliminary efficacy of QLH11811 in advanced or metastatic NSCLC patients who have progressed after prior EGFR-TKI treatment. The study consists of the following 2 phases: phase 1: dose escalation (1a) and phase 2: cohort expansion (1b).

Conditions

Interventions

DRUG

QLH11811

In Ia phase, subjects will first receive oral single dose of QLH11811, then will be observed for 7 days. If the drug is tolerated by the subjects, the subjects will continue to receive the oral repeat dose of QLH11811 for 21 consecutive days. Upon the completion of observation for DLT in the subjects (DLT observation period is the 28 days after the first dose), the subjects will continue to receive the repeat dose of QLH11811 in Cycle 2 and subsequent cycles. The dosing frequency in Cycle 2 and subsequent cycles is once daily, and each cycle has 3 weeks. The RP2D of QLH11811 is determined on the basis of comprehensive evaluation of all safety and tolerability data and all available PK, PD and efficacy data during the dose escalation phase. In phase 1b, the cohort expansion study is carried out for all cohorts in China and the United States concurrently according to the determined RP2D.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2024-12-31
Completion
2025-12-31

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 NCT05555212 on ClinicalTrials.gov