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

Part of paid clinical trials in Duarte, California.

Sponsor
Pierre Fabre Medicament
Study ID
NCT06043817
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 26, 2023
Status verified
Apr 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
345 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
  • Experimental: Part 2: RP2D Selection
  • Experimental: Part 3: Dose Expansion

Primary Outcome Measure

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 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
City of HopeHuntington BeachCalifornia92648-
City of HopeIrvineCalifornia92618-
Levine Cancer Institute - CharlotteCharlotteNorth Carolina28204-2990-
Thomas Jefferson University Research FacilityPhiladelphiaPennsylvania19107-
SCRI Oncology Partners - PPDSNashvilleTennessee37203-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-
University of Utah - Huntsman Cancer Institute - PPDSSalt Lake CityUtah84112-5550-
NEXT VirginiaFairfaxVirginia22031-2171-

Find similar trials in Duarte, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
City of Hope· Duarte, CACity of Hope· Huntington Beach, CACity of Hope· Irvine, CALevine Cancer Institute - Charlotte· Charlotte, NCThomas Jefferson University Research Facility· Philadelphia, PASCRI Oncology Partners - PPDS· Nashville, TN

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