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AMG 410 alone and with other drugs for 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

Phase 1 Interventional Amgen · NCT07094113

This trial tests whether AMG 410, given alone or with pembrolizumab or panitumumab, is safe and shows anti‑tumor activity in adults with advanced or metastatic solid tumors that have KRAS alterations.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment434 (estimated)
Ages18 Years and up
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations27 sites (Duarte, California and 26 other locations)
Trial IDNCT07094113 on ClinicalTrials.gov

What this trial studies

This first‑in‑human, open‑label Phase 1 dose‑escalation trial gives oral AMG 410 as monotherapy or combined with other agents to adults with advanced or metastatic solid tumors harboring KRAS alterations. A model‑based dose‑escalation approach will identify the maximum tolerated dose or recommended Phase 2 dose, followed by expansion cohorts at selected dose levels to explore activity in specific tumor types or molecular subgroups. Safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity will be monitored, with treatment continued until progression, unacceptable toxicity, withdrawal, or other protocol criteria. The maximum planned duration of AMG 410 treatment in the protocol is three years.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed locally advanced or metastatic solid tumors with a KRAS missense mutation or KRAS amplification, ECOG 0–1, measurable disease, adequate organ function, no suitable standard treatment options, and ability to take oral medication are ideal candidates.

Not a fit: Patients without KRAS alterations, with poor performance status (ECOG >1), significant organ dysfunction, or who have effective standard therapies available are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, AMG 410 could offer a new targeted oral treatment option for patients with KRAS‑altered tumors, including cancers that currently lack effective targeted therapies.

How similar studies have performed: Targeted inhibitors for specific KRAS variants (notably G12C agents like sotorasib and adagrasib) have shown benefit in some cancers, but many other KRAS alterations remain difficult to target and combination approaches are still under active study.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Duarte, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions KRAS Altered Advanced or Metastatic Solid TumorsNon-small cell lung cancerNSCLCColorectal cancerCRCPancreatic ductal adenocarcinomaPDACAMG 410
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.