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Clinical Trials in the USA / NCT06043817
Recruiting Phase 1/2

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

NCT06043817 · tracked via the Priya Life Science USA tracker
Sponsor
Pierre Fabre Medicament
Phase
Phase 1/2
Started
2023-09-26
Last updated
2026-10-30

Condition(s) studied

Non-Small Cell Lung CancerNSCLCEGFR/HER2 Exon 20 Insertion Mutation

Investigational drug(s) / intervention(s)

STX-721/PFL-721 (Escalated)STX-721/PFL-721 (3 dose levels)STX-721/PFL-721 (RP2D)STX-721/PFL-721 (Escalated) with platinum-based chemotherapySTX-721/PFL-721 with platinum-based chemotherapy

STX-721/PFL-721 (Escalated): STX-721/PFL-721 dose will be escalated per cBLRM-design.

STX-721/PFL-721 (3 dose levels): Participants will receive STX-721/PFL-721 at one of three dose levels.

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

STX-721/PFL-721 (Escalated) with platinum-based chemotherapy: STX-721/PFL-721 in combination with platinum-based chemotherapy dose will be escalated per iBOIN-design.

STX-721/PFL-721 with platinum-based chemotherapy: Participants will receive STX-721/PFL-721 at dose selected in Part 1b in combination with platinum-based chemotherapy.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation 2. 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 3. 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 4. Has documented tumor progression (based on radiological imaging) 5. 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 6. Has at least one measurable tumor lesion per RECIST v1.1 7. Is ≥18 years of age at the time of signing the ICF 8. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Key Exclusion Criteria: 1. 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 2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC 3. Has symptomatic brain or spinal metastases 4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy 5. 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

Primary outcome measure(s)

  • Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment — 28 days
  • Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment — 28 days
  • Part 2 RP2D Selection: C(max) of STX-721/PFL-721 — 1 year
  • Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-721 — 1 year
  • Part 2 RP2D Selection: AUC(0-t) of STX-721/PFL-721 — 1 year
  • Part 2 RP2D Selection: AUC(0-τ) of STX-721/PFL-721 — 1 year
  • Part 2 RP2D Selection: Number of participants with confirmed objective response rate (ORR) defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 per investigator assessment. — 1 year
  • Part 3 Dose Expansion: Number of participants with confirmed ORR defined as the percentage of participants with PR or CR based on RECIST v1.1 per investigator assessment. — 1 year

Trial sites (32)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
City of Hope Huntington Beach California Recruiting
City of Hope Irvine California Recruiting
Levine Cancer Institute - Charlotte Charlotte North Carolina Recruiting
Thomas Jefferson University Research Facility Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners - PPDS Nashville Tennessee Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
University of Utah - Huntsman Cancer Institute - PPDS Salt Lake City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Chris O'Brien Lifehouse Hospital Camperdown New South Wales Recruiting
EDOG Institut de Cancerologie de l'Ouest - PPDS Saint-Herblain Loire-Atlantique Recruiting
Institut Bergonie - PPDS Bordeaux France Recruiting
CHU de Lille - Hopital Claude Huriez Lille France Recruiting
Centre Léon Bérard Lyon France Recruiting
AP-HM- Hôpital de La Timone Marseille 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
Chungbuk National University Hospital Cheongju-si South Korea Recruiting
National Cancer Center Goyang-si South Korea Recruiting
CHA Bundang Medical Center, CHA University Seongnam-si South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
START - Rioja Hospital Universitario San Pedro Logroño La Rioja Recruiting
Hospital Regional Universitario de Malaga - Hospital General Málaga Malaga Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON Barcelona Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Taipei Veterans General Hospital Taipei Taiwan Recruiting

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Other trials for the same condition

Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors Active, not recruiting
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma Recruiting
Study of Oral MRT-2359 in Selected Cancer Patients Active, not recruiting
A Study of NDI 1150-101 in Patients With Solid Tumors Active, not recruiting
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06043817 on ClinicalTrials.gov ↗ ← All trials in the USA