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.

G
Greg Durm, MD

Primary Investigator

Overview

This research study is being done to test the effects of a new investigational drug therapy called AMG 510 which is being investigated for the treatment of advanced solid tumors with a specific KRAS mutation.

Description

This is 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

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

  • Conditions:
    Solid Tumor,Cancer,advanced solid turmors with KRAS mutation
  • Age: Between 18 Years - 100 Years
  • Gender: All

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.
Additional Information:
Participants will be compensated for their participation.

Updated on 13 Apr 2023. Study ID: 1806140760 (20170543)

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center