Recruiting

AMG 410 Treatment for KRAS Altered Advanced Solid Tumors

Study Aim

This clinical trial is investigating the use of AMG 410 treatment for patients with advanced solid tumors that have a specific genetic change in KRAS, to assess the safety and effectiveness of the treatment.

What is being tested

AMG 410

+ Pembrolizumab

+ Panitumumab

Drug

Who is being recruted

Bronchial Neoplasms+16

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorAmgen

Study ContactAmgen Call Center

Last updated: February 13, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 31, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a new drug called AMG 410, intended for adults with advanced or metastatic solid tumors that have changes in a gene known as KRAS. The main goal is to assess the safety and how well people can tolerate AMG 410, as well as to understand how the drug behaves in the body and its potential effectiveness against these tumors. This study is important because KRAS alterations are common in many types of cancer, and finding effective treatments could significantly improve outcomes for those affected. Participants in this study will take AMG 410 by mouth, either alone or combined with other medications. The study starts with gradually increasing doses to determine the most suitable amount that patients can handle without severe side effects. After establishing the appropriate dose, more participants will be added to further explore the drug's safety and effectiveness in specific cancer types or genetic profiles. Treatment continues until the cancer progresses, side effects become too severe, or participants choose to stop. The maximum length of time someone may receive AMG 410 in this study is three years.

Official TitleA 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

NCT07094113

Principal SponsorAmgen

Study ContactAmgen Call Center

Last updated: February 13, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

434 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsColorectal Neoplasms

Criteria

8 inclusion criteria required to participate

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.

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.

Participants must have no standard of care treatment options or have actively refused such therapy.

Show More Criteria

13 exclusion criteria prevent from participating

Therapeutic or palliative radiation therapy within 2 weeks of 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.

Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.

History of solid organ transplant.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Experimental

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

Group III

Experimental

Participants will receive escalating doses of AMG 410.

Group IV

Experimental

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.

Group 5

Experimental

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

Group 6

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Recruiting

Chris OBrien Lifehouse

Camperdown, AustraliaOpen Chris OBrien Lifehouse in Google Maps

Recruiting

The Queen Elizabeth Hospital

Woodville South, Australia

Recruiting

Peter MacCallum Cancer Centre

Parkville, Australia

Recruiting

Universitair Ziekenhuis Gent

Ghent, Belgium

Recruiting

27 Study Centers