Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

Study acronym: CDK4i
StatusRecruiting
PhasePhase 1/2
SponsorPfizer
Started

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Trial flagged as At Risk
Primary completion moved at least 3 years later Sep 23, 2026 → Oct 7, 2029
Primary endpoints added 6 → 18 primary endpoints
See other at-risk trials from Pfizer

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Oct 7, 2029 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 2 → Phase 1/2
    • Enrollment reopened
    • Enrollment increased: 362 → 430 participants
    • Interventions modified
    • Trial arms changed: 17 → 20
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 25 to 21
    • Site details revised at 39 of 39 sites
  2. Study sites: 38 to 39v23
  3. Phase: Phase 1 to Phase 2
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 337 to confirmed 362
    • Site details revised at 38 of 38 sites
    v22
  4. Phase: Phase 1/2 to Phase 1
    • Study sites: 47 to 38
    v21
  5. Study sites: 46 to 47v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 43 to 46v19
  2. Primary completion date: Mar 5, 2027 to Sep 23, 2026v18 Show 4 more changesShow less
    • Study completion date: May 4, 2028 to Nov 23, 2027
    • Study description shortened, about 269 words
    • Study arms: 16 to 17
    • Eligibility criteria expanded, about 4 words
  3. Study sites: 41 to 43v17
  4. Primary completion date: Aug 19, 2026 to Mar 5, 2027
    • Study sites: 38 to 41
    • Study completion date: Oct 19, 2027 to May 4, 2028
    v16
  5. Study sites: 37 to 38
    • Primary completion date: Jul 25, 2026 to Aug 19, 2026
    • Study completion date: Sep 24, 2027 to Oct 19, 2027
    v15
  6. Study sites: 35 to 37
    • Primary completion date: Jul 14, 2026 to Jul 25, 2026
    • Study completion date: Sep 13, 2027 to Sep 24, 2027
    v14
  7. Study sites: 34 to 35
    • Primary completion date: Feb 13, 2026 to Jul 14, 2026
    • Study completion date: Feb 13, 2026 to Sep 13, 2027
    v13
  8. Phase: Phase 1 to Phase 1/2
    • Site details revised at 1 of 34 sites
    v12
  9. Study sites: 33 to 34v11
  10. Phase: Phase 1/2 to Phase 1
    • Enrollment target: 198 to 337
    • Site details revised at 1 of 33 sites
    v10
  11. Phase: Phase 1 to Phase 1/2
    • Enrollment target: 337 to 198
    • Site details revised at 1 of 33 sites
    v9
  12. Enrollment target: 118 to 337v8 Show 8 more changesShow less
    • Primary and study completion dates: Apr 11, 2025 to Feb 13, 2026
    • Primary endpoints: 5 to 6
    • Study sites: 9 to 33
    • Interventions: Fulvestrant (Combination Product), Letrozole (Combination Product), PF-07220060 (Drug) to Enzalutamide (Combination Product), Fulvestrant (Combination Product), Letrozole (Combination Product), Midazolam (Drug), PF-07220060 (Drug)
    • Eligibility criteria expanded, about 88 words
    • Secondary endpoints: 20 to 25
    • Study description expanded, about 269 words
    • Study arms: 12 to 16
  13. Primary and study completion dates: Apr 8, 2025 to Apr 11, 2025v7
  14. Enrollment target: 52 to 118v6 Show 6 more changesShow less
    • Primary and study completion dates: Mar 27, 2024 to Apr 8, 2025
    • Primary endpoints: 4 to 5
    • Study sites: 12 to 9
    • Eligibility criteria expanded, about 173 words
    • Secondary endpoints: 19 to 20
    • Study arms: 8 to 12
  15. Study sites: 13 to 12
    • Primary and study completion dates: Apr 24, 2024 to Mar 27, 2024
    v5
  16. Study sites: 12 to 13
    • Primary and study completion dates: May 30, 2024 to Apr 24, 2024
    v4
  17. Study sites: 7 to 12
    • Primary and study completion dates: Sep 4, 2024 to May 30, 2024
    v3
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 7
    • Start date changed from estimate of Oct 1, 2020 to Sep 23, 2020
    v2
  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
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Breast Cancer
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Lung Cancer
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Colorectal Cancer
3,418 trials monitored
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and 3 more diseases
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort. Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion. In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted. In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI). In Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide. In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE. Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060. Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK. The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.
Trial Details
NCT Number NCT04557449
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Liposarcoma, Prostate Cancer, Advanced Breast Cancer, NSCLC (Non-small Cell Lung Cancer), Colorectal Cancer
Related terms Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Liposarcoma, Prostatic Neoplasms
Enrollment 430 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov