RecruitingPhase 1Phase 2NCT06043817

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

Sponsor

Pierre Fabre Medicament

Enrollment

251 participants

Start Date

Sep 26, 2023

Study Type

INTERVENTIONAL

Summary

Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a brand new drug called STX-721 (also known as PFL-721) to see if it is safe and to find the right dose. It is designed for people with advanced solid tumors or blood cancers where standard treatments are no longer working. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor or blood cancer that has progressed after standard treatment - You are in good enough overall health to participate - You are willing to follow the study requirements **You may NOT be eligible if...** - You have serious uncontrolled medical conditions - You have had recent major surgery or radiation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTX-721/PFL-721 (Escalated)

STX-721/PFL-721 dose will be escalated per cBLRM-design.

DRUGSTX-721/PFL-721 (3 dose levels)

Participants will receive STX-721/PFL-721 at one of three dose levels.

DRUGSTX-721/PFL-721 (RP2D)

Participants will receive the RP2D of STX-721/PFL-721.

Locations(24)

City of Hope

Duarte, California, United States

City of Hope

Huntington Beach, California, United States

City of Hope

Irvine, California, United States

Levine Cancer Institute - Charlotte

Charlotte, North Carolina, United States

Thomas Jefferson University Research Facility

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners - PPDS

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Utah - Huntsman Cancer Institute - PPDS

Salt Lake City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

EDOG Institut de Cancerologie de l'Ouest - PPDS

Saint-Herblain, Loire-Atlantique, France

Institut Claudius Regaud - PPDS

Toulouse, France

Gustave Roussy

Villejuif, France

Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30

Berlin, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Chungbuk National University Hospital

Cheongju-si, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Malaga, Spain

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06043817