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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

ConditionsNon-Small Cell Lung CancerNSCLCEGFR/HER2 Exon 20 Insertion Mutation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPierre Fabre Medicament

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • STX-721/PFL-721 (Escalated)

    Drug

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

  • STX-721/PFL-721 (3 dose levels)

    Drug

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

  • STX-721/PFL-721 (RP2D)

    Drug

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

Treatment groups

345 Participants
are divided into 3 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: RP2D SelectionExperimental treatment 1 intervention
Group C: Part 3: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment

Time frame
28 days
2

Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment

Time frame
28 days
3

Part 2 RP2D Selection: C(max) of STX-721/PFL-721

Time frame
1 year
4

Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-721

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pierre Fabre Medicament

Lead sponsor

Source ClinicalTrials.gov
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