AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

StatusRecruiting
PhasePhase 1
SponsorAmgen
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later across 2 updates Jun 28, 2028 → Jan 1, 2030
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Record History

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  1. Primary completion pushed from Jul 28, 2028 to Jan 1, 2030
    • Study completion pushed from Jul 28, 2028 to Feb 1, 2032
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 14 entries
  2. Study sites: 24 to 25v14
  3. Study sites: 22 to 24v13
  4. Primary and study completion pushed from Jun 28, 2028 to Jul 28, 2028
    • Study sites: 21 to 22
    v12
  5. Study sites: 20 to 21v11
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 18 to 20v10
  2. Study sites: 16 to 18v9
  3. Study sites: 14 to 16v8
  1. Trial sites expanded: 10 → 14 locationsv7
  2. Study sites: 9 to 10v6
  3. Study sites: 8 to 9v5
  4. Study sites: 6 to 8v4
  5. Trial sites expanded: 2 → 6 locations
    • Start date changed from estimate of Mar 23, 2026 to Apr 8, 2026
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Jan 21, 2026 to Mar 23, 2026
    • Study sites: 0 to 2
    • Primary completion date: Apr 23, 2029 to Jun 28, 2028
    • Study completion date: Apr 23, 2032 to Jun 28, 2028
  7. 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 objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.
Trial Details
NCT Number NCT07403721
Lead Sponsor Amgen
Conditions
(from sponsor)		 Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
Related terms Neoplasm Metastasis
Enrollment 464 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov