Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

StatusTerminated
PhasePhase 1
SponsorAmgen
Started

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Record History

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  1. Reclassified as terminated (was completed) Sponsor's reason: Sponsor decision
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Apr 10, 2026 to Jan 22, 2026
    v29
  3. Primary completion date: Jun 10, 2027 to Apr 10, 2026v28 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 220 to confirmed 37
    • Study completion date: Feb 12, 2028 to Apr 10, 2026
    • Site details revised at 27 of 27 sites
  4. Re-verified, no change to tracked fieldsv27
  5. Study sites: 26 to 27v26
Show 24 earlier versionsHide 24 earlier versions
  1. Study sites: 25 to 26v25
  2. Study sites: 24 to 25
    • Eligibility criteria expanded, about 108 words
    v24
  3. Study sites: 23 to 24
    • Primary completion date: Jan 18, 2027 to Jun 10, 2027
    • Study completion date: Sep 22, 2027 to Feb 12, 2028
    v23
  4. Enrollment target: 260 to 220
    • Study completion date: Sep 19, 2027 to Sep 22, 2027
    • Eligibility criteria shortened, about 77 words
    v22
  5. Study sites: 22 to 23
    • Primary completion date: Dec 9, 2026 to Jan 18, 2027
    • Study completion date: Aug 12, 2027 to Sep 19, 2027
    v21
  6. Primary completion date: May 13, 2026 to Dec 9, 2026
    • Study completion date: Jan 14, 2027 to Aug 12, 2027
    v20
  7. Study sites: 21 to 22v19
  8. Study sites: 20 to 21v18
  9. Study sites: 19 to 20v17
  10. Study sites: 18 to 19v16
  11. Study sites: 17 to 18v15
  12. Study sites: 16 to 17
    • Primary completion date: Feb 3, 2026 to May 13, 2026
    • Study completion date: Oct 7, 2026 to Jan 14, 2027
    • Study title revised
    v14
  13. Primary completion date: Apr 9, 2025 to Feb 3, 2026
    • Study sites: 15 to 16
    v13
  14. Study sites: 14 to 15v12
  15. Study sites: 13 to 14
    • Primary completion date: Apr 2, 2025 to Apr 9, 2025
    • Study completion date: Sep 30, 2026 to Oct 7, 2026
    v11
  16. Study sites: 11 to 13v10
  17. Study sites: 10 to 11
    • Primary completion date: Apr 8, 2025 to Apr 2, 2025
    • Study completion date: Oct 4, 2026 to Sep 30, 2026
    v9
  18. Study sites: 9 to 10v8
  19. Study sites: 8 to 9
    • Primary completion date: Apr 15, 2025 to Apr 8, 2025
    • Study completion date: Oct 11, 2026 to Oct 4, 2026
    v7
  20. Study sites: 6 to 8
    • Primary completion date: Apr 11, 2025 to Apr 15, 2025
    • Study completion date: Oct 9, 2026 to Oct 11, 2026
    v6
  21. Study sites: 4 to 6
    • Primary completion date: Apr 10, 2025 to Apr 11, 2025
    • Study completion date: Oct 8, 2026 to Oct 9, 2026
    • Eligibility criteria expanded, about 12 words
    v5
  22. Study sites: 3 to 4
    • Primary completion date: Apr 13, 2025 to Apr 10, 2025
    • Study completion date: Oct 10, 2026 to Oct 8, 2026
    v4
  23. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Oct 11, 2026 to Apr 13, 2025
    • Study sites: 0 to 3
    • Study completion date: Oct 11, 2026 to Oct 10, 2026
    • Start date changed from estimate of Jun 15, 2023 to Jun 13, 2023
  24. Study title expanded, about 9 wordsv2
  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.
Amgen
169 trials monitored
See 11 trials at risk
The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose * Determine the recommended phase 2 dose (RP2D)
Trial Details
NCT Number NCT05800964
Lead Sponsor Amgen
Conditions
(from sponsor)		 Advanced Solid Tumors
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov