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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 30, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06043817). This is a study registration, not published results. Lead sponsor: Pierre Fabre Medicament. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 345 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation. Interventions: DRUG: STX-721/PFL-721 (Escalated); DRUG: STX-721/PFL-721 (3 dose levels); DRUG: STX-721/PFL-721 (RP2D); DRUG: STX-721/PFL-721 (Escalated) with platinum-based chemotherapy; DRUG: STX-721/PFL-721 with platinum-based chemotherapy. Primary outcome measures: 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. Brief 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.