Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

RecruitingLast updated: 11 August 2025

A study evaluating efficacy of AMG 410 alone and in combination with other therapies in people with KRAS altered advanced or metastatic solid cancers.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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This study aims to assess the safety and effectiveness of an oral drug called AMG 410 when given alone or in combination with other treatment in people with KRAS-altered advanced or metastatic solid cancers. 

The trial is administered in several parts. In part 1, eligible participants will recieve an oral tablet of AMG 410 in gradually increasing doses to find the highest safe dose. A substudy of part 1 will further compare the effects of the drug in participants under fasted and fed conditions. 

Part 2 will continue testing the drug on its own in participants with KRAS altered tumors in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and other KRAS altered tumor types.

Part 3 will test AMG 410 in combination with immunotherapy (pembrolizumab) and targeted therapy (panitumumab).

Both pembrolizumab and panitumumab will be administered intravenously. 

Conditions

This trial is treating patients with advanced or metastatic solid cancers harboring KRAS alterations.

Eligibility

Inclusion

  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

  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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Amgen

Scientific Title

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

Get Support

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Cancer Connect

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Get support

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

More info for carers