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NCT06218914

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 29 versions: 23 with changes below, 6 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 18 → 12 locations
  2. Eligibility criteria expanded, about 16 words
    • Primary endpoints: details revised at 2 of 3 entries
    • Secondary endpoints: details revised at 2 of 2 entries
  3. Site details revised at 1 of 18 sitesv25
  4. Site details revised at 7 of 18 sitesv23
  5. Enrollment target: 24 to 108
    • Study sites: 17 to 18
    v22
Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 5 of 17 sitesv21
  2. Study completion date: Apr 15, 2044 to Nov 18, 2043v20
  3. Study sites: 14 to 17
    • Start date: Apr 4, 2024 to Mar 22, 2024
    v18
  4. Trial status: Active, Not Recruiting to Recruitingv16 Show 9 more changesShow less
    • Eligibility criteria expanded, about 38 words
    • Primary endpoints: 2 to 3
    • Study sites: 13 to 14
    • Study completion date: Aug 29, 2042 to Apr 15, 2044
    • Interventions: NT-112: Autologous, engineered T Cells targeting KRAS G12D (Biological) to AZD0240: Autologous, engineered T Cells targeting KRAS G12D (Biological), NT-112: Autologous, engineered T Cells targeting KRAS G12D…
    • Secondary endpoints: 7 to 2
    • Study description shortened, about 9 words
    • Study title shortened, about 7 words
    • Study arms: 1 to 2
  5. Start date: Feb 5, 2024 to Apr 4, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 12 to 13
    • Study completion date: Aug 30, 2040 to Aug 29, 2042
    v15
  6. Lead sponsor: Neogene Therapeutics, Inc. to AstraZeneca
    • Primary completion date: Aug 30, 2025 to Aug 30, 2027
    • Study completion date: Jan 2, 2040 to Aug 30, 2040
    • Site contacts updated at 2 of 12 sites
    v14
  7. Study sites: 10 to 12v12
  8. Study sites: 9 to 10v11
  9. Study sites: 7 to 9v10
  10. Study sites: 6 to 7v9
  11. Study sites revised (6)v8
  12. Site contacts updated at 1 of 6 sitesv7
  13. Study sites: 5 to 6v6
  14. Study sites: 3 to 5v5
  15. Study sites: 2 to 3v4
  16. Study sites: 1 to 2
    • Primary completion date: Jun 30, 2025 to Aug 30, 2025
    • Start date changed from estimate of Feb 15, 2024 to Feb 5, 2024
    v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Timeframe: Through study completion, an average of 2 years
Part A (Dose Escalation): Evaluate MTD and recommended dose for expansion (RDE)
Timeframe: 28 days after infusion
Part B (Expansion): Further evaluate the safety of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors
Timeframe: 28 days after infusion

Secondary (2)

Part A (Dose Escalation): Evaluate the preliminary anti-tumor activity of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Part B (Dose Expansion): Evaluate the preliminary anti-tumor activity of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors

Arms and interventions

NT-112Experimental

Part A Dose Escalation and Part B Dose Expansion of NT-112

AZD0240Experimental

Part A Dose Escalation and Part B Dose Expansion of AZD0240

Biologicals: NT-112: Autologous, engineered T Cells targeting KRAS G12D, AZD0240: Autologous, engineered T Cells targeting KRAS G12D

Sites

12 sites in 1 country