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.

Investigating the Effects of an Investigational Medication for Advanced Solid Tumors with KRAS Mutation

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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.
Participants will be compensated for their participation.

Eligibility of study

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

  • Conditions: Cancer,Solid Tumor
  • Age: 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.

Updated on 19 Feb 2024. Study ID: 1806140760 (20170543)

This study investigates the effects of an investigational medication for treating advanced solid tumors with a specific KRAS mutation. These are tumors that have a change in the KRAS gene, which can cause cancer cells to grow. The study is in Phase 1, which means it is the first time the medication is being tested in humans to see if it is safe and how it affects the body.

Participants will undergo procedures to assess the safety and effectiveness of the investigational medication. This includes monitoring how the body processes the medication, known as pharmacokinetics, and evaluating any side effects or benefits. The study will involve providing tumor samples, either from previous collections or through a new biopsy, to help researchers understand how the medication works.

  • Who can participate: Adults 18 years and older with advanced solid tumors and a specific KRAS mutation can participate. They must have tried standard treatments or be unable to benefit from them. Tumor samples are required for study participation.
  • Study details: Participants will receive the investigational medication and may need to provide tumor samples. A placebo, which is an inactive substance, is not used in this study.

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