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A Study of FWD1509 in Adults With Non-Small Cell Lung Cancer

NCT05068024 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-26

No results posted yet for this study

Summary

The purpose of this study is to characterize the safety and tolerability of FWD1509 MsOH in advanced NSCLC patients and establish the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D) in advanced NSCLC patients.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

FWD1509 MsOH

FWD1509 MsOH is administered orally once daily. The starting dose is 10 mg/day for dose-escalation phase, and the dose level to be investigated in the expansion study will depend on the emerging data. For dose-extension phase, the recommended Phase 2 dose will be administered.

Sponsors & Collaborators

  • WuXi Clinical

    collaborator INDUSTRY

  • Forward Pharmaceuticals Co., Ltd.

    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
2021-08-23
Primary Completion
2022-10-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

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 NCT05068024 on ClinicalTrials.gov