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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FWD1509 MsOH for individuals with advanced non-small cell lung cancer (NSCLC). The main goal is to determine the treatment's safety and establish the best dose for future studies. Participants should have NSCLC with specific genetic changes, such as EGFR or HER2 mutations, and must have tried other treatments without success. The trial is open to those with at least one measurable tumor and whose cancer has progressed despite previous treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that FWD1509 MsOH is likely to be safe for humans?

Research has shown that FWD1509 MsOH is being tested for safety in people with advanced non-small cell lung cancer (NSCLC). This treatment is in the early stages of testing, so information about its safety in humans remains limited. These early trials aim to find the safest doses and identify any side effects.

As a Phase 1 and 2 trial, the main focus is on understanding how well people can tolerate the treatment and determining the right dose. The treatment is closely monitored for any health issues it might cause. Participants might experience some side effects, but the goal is to identify these and ensure they are manageable.

Currently, no specific reports detail how people have reacted to FWD1509 MsOH. Those considering joining the trial should know that the treatment's safety is still under study. Prospective participants can ask the trial team for more information about observations so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about FWD1509 MsOH because it offers a new approach to treating non-small cell lung cancer (NSCLC) with EGFR or HER2 genetic alterations. Unlike the standard treatments, which often involve drugs like tyrosine kinase inhibitors or chemotherapy, FWD1509 MsOH is designed to specifically target and inhibit these genetic mutations more precisely. This targeted mechanism could potentially lead to more effective outcomes with fewer side effects, improving the quality of life for patients.

What evidence suggests that FWD1509 MsOH might be an effective treatment for lung cancer?

Research has shown that FWD1509 MsOH targets specific genetic changes in patients with non-small cell lung cancer (NSCLC). This treatment blocks certain proteins that promote cancer growth. Early studies found that FWD1509 MsOH can be safely administered to patients with advanced NSCLC. Although detailed efficacy data remains limited, targeting genetic changes such as EGFR or HER2 offers a promising personalized approach for treating this cancer. Researchers continue to determine the optimal dose for maximum benefit. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05068024

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

2. withpower.com withpower.com/trial/phase-2-carcinoma-non-small-cell-lung-7-2021-f311c

FWD1509 for Lung Cancer · Recruiting Participants ... This trial is testing a new oral medication called FWD1509 MsOH in patients with advanced lung cancer who have specific genetic mutations.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05068024/a-study-of-fwd1509-in-adults-with-non-small-cell-lung-cancer

A Study of FWD1509 in Adults With Non-Small Cell Lung ... The purpose of this study is to characterize the safety and tolerability of FWD1509 MsOH in advanced NSCLC patients and establish the maximum ...

4. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT05068024

NCT05068024 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 ( ...

5. stopcancernyc.org stopcancernyc.org/lung-cancer-trials

Lung Cancer Trials | Stand Up To Cancer This study is about testing different treatments for non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable).

6. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/egfr-mutant-selective-inhibitor-fwd1509-msoh

Clinical Trials Using EGFR Mutant-selective Inhibitor ... Review the clinical trials studying egfr mutant-selective inhibitor fwd1509 msoh on this list and use the filters to refine the results by age and location.