Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Study acronym: KAT6
StatusRecruiting
PhasePhase 2
SponsorPfizer
Started

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Trial flagged as At Risk
Primary completion moved at least 45 days later Jul 13, 2029 → Aug 27, 2029
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 13, 2029 to Aug 27, 2029 Show 5 more changesShow less
    • Study sites: 44 to 43
    • Study completion date: Aug 10, 2029 to Aug 27, 2029
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 23 entries
    • Publications: details revised at 2 of 2 entries
  2. Study sites revised (44)v28
  3. Phase: Phase 1 to Phase 2
    • Primary completion date: Feb 3, 2028 to Jul 13, 2029
    • Study sites: 41 to 44
    • Study completion date: Sep 22, 2029 to Aug 10, 2029
    v27
  4. Primary completion date: Jan 30, 2028 to Feb 3, 2028
    • Study completion date: Jan 30, 2028 to Sep 22, 2029
    v26
  5. Enrollment target: 186 to 320v25 Show 6 more changesShow less
    • Primary and study completion dates pushed to Jan 30, 2028
    • Interventions: Fulvestrant (Drug), Letrozole (Drug), PF-07220060 (Drug), PF-07248144 (Drug), Palbociclib (Drug) to Fulvestrant (Drug), Letrozole (Drug), PF-07220060 (Drug), PF-07248144 (Drug), PF-07850327, ARV-471, vepdegestrant (Drug), Palbociclib (Drug)
    • Eligibility criteria expanded, about 79 words
    • Secondary endpoints: 25 to 23
    • Study description expanded, about 32 words
    • Study arms: 8 to 10
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 56 to 41
    • Primary completion date: May 9, 2025 to Aug 13, 2025
    • Study completion date: Nov 8, 2026 to Mar 7, 2027
    v24
  2. Study sites: 54 to 56v23
  3. Study sites: 53 to 54v22
  4. Study sites: 51 to 53v21
  5. Site details revised at 1 of 51 sitesv20
  6. Study sites: 50 to 51v19
  7. Re-verified, no change to tracked fieldsv18
  8. Study sites: 48 to 50v17
  9. Study sites: 47 to 48v16
  10. Enrollment target: 200 to 186
    • Study sites: 46 to 47
    • Primary completion date: Apr 21, 2026 to May 9, 2025
    • Study completion date: Sep 23, 2027 to Nov 8, 2026
    v15
  11. Enrollment target: 108 to 200v14 Show 5 more changesShow less
    • Interventions: Fulvestrant (Drug), Letrozole (Drug), PF-07248144 (Drug), Palbociclib (Drug) to Fulvestrant (Drug), Letrozole (Drug), PF-07220060 (Drug), PF-07248144 (Drug), Palbociclib (Drug)
    • Eligibility criteria expanded, about 138 words
    • Secondary endpoints: 22 to 25
    • Study description expanded, about 36 words
    • Study arms: 11 to 8
  12. Primary completion date: May 8, 2024 to Apr 21, 2026
    • Study sites: 44 to 46
    • Study completion date: Oct 24, 2025 to Sep 23, 2027
    v13
  13. Study sites: 43 to 44
    • Primary completion date: Nov 15, 2023 to May 8, 2024
    • Study completion date: Apr 18, 2025 to Oct 24, 2025
    v12
  14. Site details revised at 3 of 43 sitesv11
  15. Primary endpoints revised (5)v10 Show 5 more changesShow less
    • Study sites: 22 to 43
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 19 to 22
    • Study description shortened, about 11 words
    • Study arms: 10 to 11
  16. Study sites: 15 to 22v9
  17. Study sites: 13 to 15v8
  18. Enrollment target: 110 to 108
    • Study sites: 12 to 13
    • Primary completion date: Jul 15, 2024 to Nov 15, 2023
    • Study completion date: Dec 17, 2025 to Apr 18, 2025
    v7
  19. Primary completion date: Jul 9, 2024 to Jul 15, 2024
    • Study completion date: Dec 11, 2025 to Dec 17, 2025
    • Study sites revised (12)
    v6
  20. Study sites: 13 to 12
    • Primary completion date: Jul 26, 2024 to Jul 9, 2024
    • Study completion date: Dec 28, 2025 to Dec 11, 2025
    v5
  21. Study sites: 12 to 13v4
  22. Study sites: 7 to 12
    • Primary completion date: Sep 13, 2024 to Jul 26, 2024
    • Study completion date: Feb 15, 2026 to Dec 28, 2025
    v3
  23. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoints revised (5)
    • Study sites: 1 to 7
    • Primary completion date: Sep 6, 2024 to Sep 13, 2024
    • Study completion date: Feb 8, 2026 to Feb 15, 2026
    • Start date changed from estimate of Nov 8, 2020 to Nov 16, 2020
    • Secondary endpoints revised (19)
  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.
Pfizer
441 trials monitored
See 30 trials at risk
Breast Cancer
5,481 trials monitored
See 311 trials at risk
Lung Cancer
4,820 trials monitored
See 267 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,100 trials monitored
See 174 trials at risk
and 1 more disease
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents
Trial Details
NCT Number NCT04606446
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov