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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    130
  • sponsor
    Forward Pharmaceuticals Co., Ltd.
Updated on 19 April 2022
systemic therapy
measurable disease
neutrophil count
EGFR
kidney function test
lung carcinoma

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.

Description

This study will be a first-in-human study evaluating the safety and tolerability of FWD1509 MsOH in subjects with advanced NSCLC, when FWD1509 MsOH is administered once daily as a single agent. FWD1509 MsOH is an oral TKI (Tyrosine Kinase Inhibitor) that blocks the function of tyrosine kinase. TKIs such as gefitinib, erlotinib or afatinib are recommended as the first-line therapy for EGFR mutated (exon 19 deletions or L858R point mutations in exon 21) NSCLC patients. However, the majority (>50%) of patients will develop acquired resistance after initially responding to gefitinib or erlotinib due to the occurrence of secondary mutations (mostly T709M) in EGFR. Osimertinib was subsequently developed to such secondary mutations, but for EGFRex20ins mutations, on which there is still no effective therapies focusing. FWD1509 MsOH is new generation EGFR-TKI targeting EGFR mutations such as exon 19 deletion, L858R substitution as well as T790M mutations. In particular, FWD1509 MsOH targets the EGFRex20ins mutation in NSCLC.

The development of FWD1509 MsOH at this stage is mainly focused on treatment of NSCLC tumors with EGFRex20ins mutations, followed by further exploration against other targets.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment FWD1509 MsOH
Clinical Study IdentifierNCT05068024
SponsorForward Pharmaceuticals Co., Ltd.
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Study-Wide Eligibility (Across All Study Parts)
Have histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB/IIIC or IV) [JACC edition 8], and inclusion of Stage IIIB only if not a candidate for curative therapy
Must have sufficient tumor tissue (either archived sample or recent biopsy) available for analysis
Phase 1a Dose-escalation part: EGFR mutations (including but not limited to L858R, exon 19 deletion, T790M, ex20ins, 21exon, G719 X, S7681\L861Q, etc) should be confirmed by previously documented evidence or central lab
Phase 1b Dose-expansion part and Phase 2: Have an EGFR in-frame exon 20 insertion test by any central lab
Must have at least one measurable lesion as defined by response evaluation criteria in
solid tumors (RECIST v1.1)
Prior anti-cancer therapies
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease
Disease progressed, or intolerant to at least one line of systematic therapies including but not limited to any EGFR-target therapies or immunotherapies, for metastatic / local relapsed settings
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix 2)
Male or female adult participants (aged 18 years or older, or as defined per local
Estimated minimum life expectancy of 3 months or more
regulations)
Adequate organ function at baseline
Bone marrow function
Absolute neutrophil count (ANC)≥1.5 x 10^9/L
Platelets ≥100 x 10^9/L
Hepatic function
Hemoglobin ≥9 g/dL, criteria must be met without a transfusion within 2 weeks of the blood draw
AST and ALT ≤3 x upper limit of normal (ULN); if liver metastases, then ≤ 5 x ULN
Renal function
Bilirubin ≤1.5 x ULN or ≤3 x ULN in the presence of documented Gilbert's Syndrome
QTc-related criteria
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula
Creatinine clearance ≥50 ml/min (calculated by Cockcroft and Gault equation (Cockcroft DW, 1976) (Appendix 3)
A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria

Subjects who meet any of the following criteria are not to be enrolled in this
study
Have been diagnosed with another primary malignancy other than NSCLC except for patients with adequately treated non-melanoma skin cancer, cervical cancer in situ or definitively treated non-metastatic prostate cancer, or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy
Received small-molecule anticancer therapy including cytotoxic chemotherapy, biological agents and investigational agents, ≤21 days prior to first dose of FWD1509 MsOH, or received prior EGFR TKIs (e.g., gefitinib, erlotinib, Osimertinib) ≤7 days prior to the first dose FWD1509 MsOH
Received strong CYP3A inhibitors and inducers within 2 weeks prior to the first dose of FWD1509 MsOH. They should be discontinued at least 2 weeks prior to the first dose of FWD1509 MsOH and avoided throughout the study duration
Received radiotherapy ≤14 days prior to the first dose of FWD1509 MsOH or have not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose of FWD1509 MsOH
Received concomitant medications (e.g., statins) which are substrates of BCRP, p-glycoprotein or OATP1B1/1B3 (dose escalation part of phase 1 study)
Have undergone major surgery within 28 days prior to first dose of FWD1509 MsOH. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed
Brain Metastasis: Have known active brain metastases (have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions), except for the following
conditions
Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before the first dose of FWD1509 MsOH and have no evidence of new or enlarging brain metastases
Requiring corticosteroids to control symptoms within 7 days prior to the first dose of FWD1509 MsOH or during study period; patients previously treated for CNS metastases who are clinically stable, have no new lesions, and who do not need treatment with a corticosteroid within the 7 days before the first dose of FWD1509 MsOH and during study period are allowed to be enrolled
Have significant, uncontrolled, or active cardiovascular disease
Have current spinal cord compression (symptomatic or asymptomatic and detected by
Have significant, uncontrolled, or active renal disease
radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic)
Have a known history of uncontrolled hypertension (per institution practice); participants with hypertension should be under treatment on study entry to control blood pressure
Have any abnormal changes in the cornea or retina that may increase the risk of ocular toxicity during screening
Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV); testing is not required in the absence of history
Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis
Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period
Have gastrointestinal illness or disorder that could affect oral absorption of FWD1509 MsOH
Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug
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