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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

Interventions

DRUG

STX-721/PFL-721 (Escalated)

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

DRUG

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

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

DRUG

STX-721/PFL-721 (RP2D)

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

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2029-12-01
Completion
2029-12-01
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043817 on ClinicalTrials.gov