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EGFR Tyrosine Kinase Inhibitor

STX-241 for Lung Cancer (STX-241 FIH Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Pierre Fabre Medicament

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease progression on a 3rd generation EGFR TKI-based therapy received at any prior line of treatment

Tumor mutation profile requirements met

Must not have

Woman who are breast feeding

Toxicities from prior therapy exceeding specified grade

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial aims to test the safety, effectiveness, and recommended dosage of a new drug called STX-241 in patients with advanced lung cancer that has not responded to previous treatments. The drug is designed

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has stopped responding to third-generation EGFR TKI treatments due to specific mutations. Participants must have measurable disease and be able to perform daily activities without significant assistance.

What is being tested?

The study tests STX-241, a new drug designed for NSCLC resistant to previous treatments. It's a first-in-human trial aiming to find the safest dose, understand how the body processes it, and see if it works against certain lung cancers.

What are the potential side effects?

As this is a first-in-human study of STX-241, potential side effects are not fully known yet but may include typical reactions related to EGFR inhibitors such as diarrhea, rash, nail changes, and dry skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened despite treatment with a specific lung cancer medication.

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My tumor's genetic testing meets the study's requirements.

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I am fully active or can carry out light work.

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My lung cancer is advanced, cannot be surgically removed, and has specific EGFR mutations.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently breastfeeding.

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My side effects from previous treatments are not severe.

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I have not had major surgery in the last 14 days.

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My cancer has not spread to my brain or spinal cord in a way that is uncontrollable.

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I do not have any active infections.

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I have tested positive for COVID-19 or suspect I am infected.

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I have heart problems or significant heart disease.

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I do not have any uncontrolled illnesses.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: STX-241Experimental Treatment1 Intervention

Part 1: Dose Escalation and Backfilling components (Phase Ia) Participants will receive oral (PO) STX-241 twice daily (BID) at fixed doses: 10 mg, 20 mg, 40 mg, 80 mg, 120 mg, 180 mg on a continuous dosing schedule Part 2: Dose Range Optimization (Phase Ib) Participants will receive oral (PO) STX-241 twice daily (BID) at fixed doses selected from Part 1 within the OBD-MTD range for Part 2 on a continuous dosing schedule. Part 3: Expansion at RP2D (Phase II) Participants will receive oral (PO) STX-241 twice daily (BID) at RP2D dose on a continuous dosing schedule.

0 / 14Eligibility criteria met

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Who is running the clinical trial?

Pierre Fabre MedicamentLead Sponsor

77 Previous Clinical Trials

19,540 Total Patients Enrolled

~114 spots leftby Nov 2027

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