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Taking people in ItalyPhase 1

AMG 410 Tested Alone or With Other Drugs in Advanced KRAS Solid Tumors

Tests AMG 410, alone or combined, in adults with advanced KRAS-altered solid tumors.

Key facts

Who runs it
Amgen
Where
Milan, Pisa, and Verona, ItalySee the 3 sitesAlso in 13 other countries, 36 sites
Trial code
Registry title
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
434 people, planned
Started
31 Jul 2025
Expected to end
20 Apr 2031
Type of study
Interventional, 6 groups
Treatments tested
  • AMG 410
  • Pembrolizumab
  • Panitumumab
Record updated
30 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic solid tumors that carry a KRAS gene change and who have no standard treatment options left.

Age
18 years or older (or older than the legal age in the country, if that is higher than 18).
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic cancer that can be measured on scans (RECIST v1.1). Good daily function (ECOG 0 or 1).
Earlier treatment
No standard treatment options left, or the person has actively refused such treatment. No anti-tumor therapy within 28 days before the first dose.
Biomarker or test result
Any missense mutation in the KRAS gene, or KRAS amplification shown by a validated test.

Main reasons for not taking part

  • Untreated symptomatic brain or leptomeningeal metastases
  • Another cancer within the past 5 years
  • History of solid organ transplant
  • HIV, hepatitis B, hepatitis C or active SARS-CoV-2 infection
  • Major surgery within 28 days before the first dose

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Age ≥ 18 years (or > legal age within the country if it is older than 18 years)
  • 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
  • Participants must have no standard of care treatment options or have actively refused such therapy
  • Able to swallow and retain per oral administered study treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator
  • Adequate organ function
  • 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)

Who cannot take part

  • 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
  • Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment
  • 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
  • Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment
  • Major surgery within 28 days of first dose of study treatment
  • History of other malignancy within the past 5 years
  • History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis)
  • History of solid organ transplant
  • 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)
  • 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
  • Untreated symptomatic central nervous system or leptomeningeal metastases
  • Uncontrolled pleural effusion and/or ascites

Where in Italy

Also in 13 other countries, 36 sites

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitataVerona, ItalyTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 6 groups in the trial

  • Part 1: Monotherapy Dose ExplorationTreatment being tested

    Participants will receive escalating doses of AMG 410.

    Treatment: AMG 410

  • Part 1: Food Effect Substudy CohortTreatment being tested

    A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions.

    Treatment: AMG 410

  • Part 1: China-specific CohortTreatment being tested

    Participants identified through regionally approved molecular KRAS testing will receive AMG 410.

    Treatment: AMG 410

  • Part 2: Monotherapy Dose ExpansionTreatment being tested

    Monotherapy dose expansion of AMG 410 may proceed in KRAS altered tumors in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and other KRAS altered tumor types.

    Treatment: AMG 410

  • Part 3a: Combination Therapy Dose Exploration and Dose ExpansionTreatment being tested

    Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors.

    Treatment: AMG 410 and Pembrolizumab

  • Part 3b: Combination Therapy Dose Exploration and Dose ExpansionTreatment being tested

    Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC.

    Treatment: AMG 410 and Panitumumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Plain-language title
AMG 410 Tested Alone or With Other Drugs in Advanced KRAS Solid TumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 July 2026