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.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: advanced solid turmors with KRAS mutation | Cancer | Solid Tumor
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures Men or women greater than or equal to 18 years old Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through DNA sequencing. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
  • Part 1 (Dose Exploration) - Subjects willing to provide archived tumor samples (fresh frozen sample or formalin fixed, paraffin embedded [FFPE] sample collected within 5 years) or willing to undergo pretreatment tumor biopsy.
  • Part 2 (Dose Expansion) - Willing to undergo pre-treatment tumor biopsy. Subjects can be allowed to enroll without undergoing tumor biopsy upon agreement with Investigator and the Medical Monitor if tumor biopsy is not feasible.

For a full list of participation criteria, please visit clinicaltrials.gov.

Recruitment Status

Open

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