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

NCT05068024 | Unknown Phase 1 FDA Drug

• 1 other identifier: FWDCT-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

FWD1509 MsOH in advanced non-small cell lung cancer; Forward Pharma; Forward; FWD1509; NSCLC; MsOH; FWD-001; First-in-human; Non-small cell lung cancer; Advanced solid malignancies; Solid malignancies; Solid tumor; EGFR; EGFR ex20ins; EGFR mutation; TKI; HER2

Outcome Measures

Primary Outcomes (1)

• 22-30 participants with treatment-related adverse events as assessed based on CTCAE v5.0.

  Adverse events (AE), serious adverse events (SAE) and adverse events of special interest (AESI) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE 5.0) grading system, changing from baseline and each treatment cycle (1 cycle=3 weeks). An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment.

  18 months

Secondary Outcomes (14)

• Cmax: Maximum Observed Plasma Concentration for FWD1509 MsOH

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for FWD1509 MsOH

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

• T1/2: Terminal Half-life for FWD1509 MsOH

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

• AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to infinite time for FWD1509 MsOH

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for FWD1509 MsOH

  Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose

Study Arms (1)

Treatment of NSCLC patients with EGFR or HER2 genetic alterations

EXPERIMENTAL

Drug: FWD1509 MsOH

Interventions

FWD1509 MsOH DRUG

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.

Treatment of NSCLC patients with EGFR or HER2 genetic alterations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have sufficient tumor tissue (either archived sample or recent biopsy) available for analysis:
• Phase 1 Dose-escalation part: EGFR and HER2 mutations (including but not limited toL858R, exon 19 deletion, T790M, ex20ins, 21exon, G719X, S768I, L861Q, etc. for EGFR and A775YVMG, C776insVC, P780ins GSP etc. for HER2) should be confirmed by previously documented evidence or central lab
• Patients with both EGFR and HER2 mutations may be included in the dose escalation phase
• Phase 1 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
• Male or female adult participants (aged 18 years or older, or as defined per local regulations)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Minimum life expectancy of 3 months or more
• Adequate organ function at baseline
• Bone marrow function
• Absolute neutrophil count (ANC)≥1.5 x 10\^9/L
• Platelets ≥100 x 10\^9/L

You may not qualify if:

• Received anticancer therapy including cytotoxic chemotherapy, biological products and investigational agents, ≤ 21 days prior to first dose of FWD1509 MsOH; or received prior EGFR TKIs (e.g., gefitinib, erlotinib or osimertinib) ≤7 days prior to the first dose FWD1509 MsOH
• 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 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 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 (see Appendix 6)
• 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 current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic)
• Have significant, uncontrolled, or active cardiovascular disease
• QCc-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
• A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome
• Have significant, uncontrolled, or active renal disease

Sponsors & Collaborators

• Forward Pharmaceuticals Co., Ltd.: lead
• WuXi Clinical: collaborator

Study Sites (2)

Gabrail Cancer Center

Canton, Ohio, 44718, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jo-Han Wang, Project Manager

CONTACT

+1-647-649-2850; jo-han.wang@wuxiapptec.com

Ling Zeng

CONTACT

+86 15010623457; zengl@forward-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 5, 2021
• Study Start: August 23, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

US (2)