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Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）

NCT04687423 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-08-18

No results posted yet for this study

Summary

A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II)

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

FCN-011

FCN-011 will be given orally in ascending doses starting at 50 mg Q12h or 100mg QD until the maximum tolerated dose or recommended dose is reached.

Sponsors & Collaborators

  • Fochon Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Hu Xi chun, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2023-10-31
Completion
2024-03-31

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 NCT04687423 on ClinicalTrials.gov