A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

Study acronym: FLAGSHP-1
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Jun 2026 to Jun 1, 2026
    • Eligibility criteria expanded, about 19 words
  2. Enrollment target: estimated 200 to confirmed 90
    • Primary completion date changed from estimate of Nov 2025 to Feb 1, 2026
    • Study completion date: Feb 2026 to Jun 2026
    v20
  3. Study sites: 15 to 14
    • Primary completion date: May 2025 to Nov 2025
    • Study completion date: Jul 2025 to Feb 2026
    v19
  4. Primary completion date: May 2024 to May 2025
    • Study completion date: May 2024 to Jul 2025
    v18
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 14 to 15v16
  2. Study sites: 13 to 14v15
  3. Study sites: 12 to 13v14
  4. Study sites: 11 to 12v13
  5. Study sites: 10 to 11v12
  6. 2 versions Re-verified since Nov 16, 2022, no change to tracked fieldsv10-v11
  7. Study sites: 9 to 10
    • Interventions: Cetuximab (Drug), ERAS-601 (Drug) to Cetuximab (Drug), ERAS-601 (Drug), Pembrolizumab (Drug)
    • Study arms: 4 to 5
    v9
  8. Study sites: 8 to 9v8
  9. Study sites: 7 to 8v7
  10. Enrollment target: 170 to 200v6 Show 5 more changesShow less
    • Study sites: 6 to 7
    • Interventions: ERAS-601 (Drug), MEK inhibitor (Drug) to Cetuximab (Drug), ERAS-601 (Drug)
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 7 words
    • Study arms: 5 to 4
  11. Study title shortened, about 1 wordv5
  12. Study sites: 5 to 6v4
  13. Study sites: 4 to 5v3
  14. Site details revised at 1 of 4 sitesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
* To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors. * To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.
Trial Details
NCT Number NCT04670679
Lead Sponsor Erasca, Inc.
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors
Related terms Chordoma, Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms, Noonan Syndrome, Squamous Cell Carcinoma of Head and Neck
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov