FWD1509 for Lung Cancer
(FWD1509 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Forward Pharmaceuticals Co., Ltd.

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

Disqualifiers: Other malignancy, Brain metastasis, Cardiovascular, others

No Placebo Group

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.

Research Team

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.

See 6 more

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.

See 10 more

Trial 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 (Unknown)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Treatment of NSCLC patients with EGFR or HER2 genetic alterationsExperimental Treatment1 Intervention