First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Sponsor: Scorpion Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06043817

Patient View

Study STX-721-101 is an open-label, Phase 1/2 trial assessing STX-721's safety, tolerability, and preliminary efficacy in NSCLC patients with EGFR exon 20 insertion mutations. Eligible participants are adults with advanced NSCLC, ECOG 0-1, and no concurrent T790M/C797S mutations. Interventions include dose escalation and RP2D administration of STX-721.

Patient Parameters

Program Overview

Study STX-721-101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion (ex20ins) mutations.

Eligibility Criteria

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 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 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

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