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Closed (no longer recruiting)Last updated: 2 February 2024

This phase I trial is trying to find the optimal dose of an oral drug (AMG 510) to treat patients with advanced cancers with a specific KRAS mutationA Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With a Specific KRAS Mutation

Clinical summary

Summary

This is a non-randomised, open label study for people with advanced cancers that have specific KRAS mutations. Enrolment into the dose exploration cohorts can be from any eligible solid tumour type. Dose excalation will begin at a planned dose level of 180 mg.

Conditions

This trial is treating patients with advanced cancers with specific KRAS mutations.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 100

Phase

I

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With a Specific KRAS Mutation

Eligibility

Inclusion

  • Men or women greater than or equal to 18 years old.
  • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.

Exclusion

  • Active brain metastases from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

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