ClinicaliQ Trial Snapshot
- AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors — Recruiting • Phase I • Oncology • NCT07094113.
- What is being tested: AMG 410, a novel KRAS-targeted agent, is being evaluated as monotherapy and in combination regimens for safety, tolerability, pharmacokinetics, and anti-tumour efficacy in a first-in-human study of patients with KRAS-altered advanced or metastatic solid tumours.
- Patient eligibility overview: The trial recruits adults with advanced or metastatic solid tumours that harbour KRAS mutations; specific tumour types and prior treatment requirements are protocol-defined, though this represents a broad patient population with difficult-to-treat malignancies.
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What This Trial Is Studying
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations. This is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)-the highest dose with acceptable safety and…
Eligibility Snapshot
- : 1. Age ≥ 18 years (or > legal age within the country if it is older than 18 years). 2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.
- Participants must have no standard of care treatment options or have actively refused such therapy. 4. Able to swallow and retain per oral administered study treatment. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator. 7. Adequate organ function. 8. Archival (formalin-fixed, paraffin-embedded [FFPE]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.