RightFit
RecruitingPhase 1

AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

A Phase 1/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AMG 410 alone or with other drugs in adults with solid tumors that have certain KRAS gene changes and have grown nearby or spread. This is the first study of AMG 410 in people, and it aims to find a dose with manageable side effects and learn how the drug acts in the body and may fight cancer.

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 manageable side effects-or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18, or above your country's legal age if it is older than 18.
  • Tests confirm that your cancer has grown nearby or spread and has a KRAS gene mutation or extra copies of the KRAS gene.
  • You have no standard treatment options left, or you have chosen not to receive them.
  • You can swallow the study medicine and keep it down.
  • You can do all usual activities, or only have limits on hard physical activity.
  • Your cancer can be measured using the study's rules.
  • Your organs work well enough for the study.
  • A stored tumor sample from the past 5 years is available, or you may have a biopsy to collect one before treatment.

Who can't join

  • You have untreated cancer spread to the brain, spinal cord, or their lining that causes symptoms, or uncontrolled fluid buildup around the lungs or in the belly.
  • You had another cancer within the past 5 years or have had a solid organ transplant.
  • You have an active infection, or signs of a sudden or uncontrolled infection needing antibiotics through a vein within 7 days before treatment.
  • You have a history of blood clots in arteries or veins, including a stroke, mini-stroke, or clots in the lungs or deep veins.
  • You have current or past HIV, hepatitis B, or hepatitis C, or an active infection with the virus that causes COVID-19.
  • You received a live or weakened-live vaccine, cancer drug treatment, or major surgery within 28 days before study treatment.
  • You had radiation treatment within 2 weeks before study treatment, or side effects from past cancer treatment have not improved to mild or better.
  • You have another serious health problem that the study doctor believes would make the study unsafe for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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. 3. 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). Exclusion Criteria: 1. Untreated symptomatic central nervous system or leptomeningeal metastases. 2. Uncontrolled pleural effusion and/or ascites. 3. History of other malignancy within the past 5 years. 4. Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment. 5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis). 6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment. 7. History of solid organ transplant. 8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment. 9. Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 10. Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1. 11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment. 12. Major surgery within 28 days of first dose of study treatment. 13. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

Study sites (10)

CA

GA

MA

MO

NC

PA

TN

TX

VA