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A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

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NCT05975073

Sponsored by Amgen (industry) · AMGN — their whole pipeline →.

Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
53actual
Sites
27
Countries
Australia, Canada, Denmark +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-08-01actualWhen the study began enrolling
Primary completion2026-02-25actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-03-26actualThe whole study's end, after follow-up
First posted2023-08-03actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-04-22actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • MTAP-null Non-Small-Cell Lung Cancer
  • MTAP-null Solid Tumors

Interventions

  • Drug: Anvumetostat — also filed as AMG 193
  • Drug: IDE397

Primary outcomes

what the primary-completion date above is the date OF
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
measured Day 1 up to Day 21
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
measured Day 1 up to approximately 2.5 years
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
measured Day 1 up to approximately 2.5 years
Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
measured Day 1 up to approximately 2.5 years

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