FWD1509 for Lung Cancer

(FWD1509 Trial)

Recruiting at 1 trial location

Overseen By Jo-Han Wang, Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Forward Pharmaceuticals Co., Ltd.

Must not be taking: CYP3A inhibitors, CYP3A inducers, Statins

Disqualifiers: Other malignancy, Brain metastasis, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral medication called FWD1509 MsOH in patients with advanced lung cancer who have specific genetic mutations. The medicine works by blocking proteins that help cancer cells grow, especially in cases where other treatments have failed.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong CYP3A inhibitors and inducers, at least 2 weeks before starting the study drug. Additionally, medications that are substrates of BCRP, p-glycoprotein, or OATP1B1/1B3 should be avoided during the study.

Eligibility Criteria

Adults with advanced non-small cell lung cancer (NSCLC) who've had at least one prior systemic therapy can join this trial. They need a measurable tumor, good performance status, and adequate organ function. Major surgery within the last 28 days or certain health conditions like uncontrolled heart disease disqualify participation.

Inclusion Criteria

My lung cancer is at an advanced stage (Stage IIIB/IIIC or IV).

You must have at least one spot that can be measured and checked for changes according to specific guidelines.

I have been treated with medication for my advanced or spread cancer.

Exclusion Criteria

I haven't taken strong CYP3A affecting drugs in the last 2 weeks.

I haven't had cancer treatment in the last 21 days, or EGFR inhibitors in the last 7 days.

I have spinal cord compression or cancer spread to the lining of my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FWD1509 MsOH once daily as a single agent to evaluate safety, tolerability, and establish the maximum tolerable dose

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FWD1509 MsOH

Trial Overview The study is testing FWD1509 MsOH's safety and determining the highest dose patients with NSCLC can tolerate without severe side effects. It aims to find the optimal phase 2 dose based on how well participants handle it.

Participant Groups

Group I: Treatment of NSCLC patients with EGFR or HER2 genetic alterations Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Forward Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

2

Recruited

130+

WuXi Clinical

Industry Sponsor

Trials

2

Recruited

110+

WuXi Clinical

Collaborator

Trials

2

Recruited

110+