Recruiting Phase 1 / Phase 2

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

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About this study

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.

Condition: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
Tested: STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels), STX-721/PFL-721 (RP2D)
Sponsor: Pierre Fabre Medicament

Who can join

Age: 18 years and older
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 10

Minimum age: 18 years
Study condition: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation
Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR/HER2 exon 20 insertion mutations confirmed by qualified local laboratories
Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not more than 2, prior lines of approved treatment for advanced or metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated
Has documented tumor progression (based on radiological imaging)
Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling
Has at least one measurable tumor lesion per RECIST v1.1
Is ≥18 years of age at the time of signing the ICF
Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion 5

Has a tumor that is known to harbor EGFR ex20ins p.H773\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations
Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC
Has symptomatic brain or spinal metastases
Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments

Where

25 sites, 25 recruiting

EDOG Institut de Cancerologie de l'Ouest - PPDS

Saint-Herblain, Loire-Atlantique, France

Recruiting

Institut Claudius Regaud - PPDS

Toulouse, France

Recruiting

Gustave Roussy

Villejuif, France

Recruiting

Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30

Berlin, Germany

Recruiting

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Recruiting

Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Recruiting

and 19 more sites on ClinicalTrials.gov

Contact

Adele De MASSON, clinical devlopment director, MD, PhD

33 772344916 PFL721_medical.team@pierre-fabre.com

Potential match only. Final eligibility is determined by the study team.