A Phase 1 interventional study of AMG 410 and Pembrolizumab in KRAS Altered Advanced or Metastatic Solid Tumors, sponsored by Amgen. Recruiting at 39 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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.
This is a multicenter, multinational, open-label Phase 1/1b study designed to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of AMG 410 in adult participants with advanced or metastatic solid tumors characterized by KRAS alterations.
The study will begin with a dose-escalation phase, during which AMG 410 will be administered orally, either as monotherapy or in combination with other agents. Dose escalation will follow a model-based approach to identify the MTD or RP2D.
Following dose escalation, additional expansion cohorts may be enrolled at selected dose levels to further characterize the safety profile, PK/PD relationships, and preliminary efficacy in specific tumor types or molecular subgroups.
Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria. The maximum duration of AMG 410 administration in this study is 3 years.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 434 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive escalating doses of AMG 410.
Drug: AMG 410
A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions.
Drug: AMG 410
Participants identified through regionally approved molecular KRAS testing will receive AMG 410.
Drug: AMG 410
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.
Drug: AMG 410
Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors.
Drug: AMG 410 · Drug: Pembrolizumab
Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC.
Drug: AMG 410 · Drug: Panitumumab
Administered as an oral tablet.
Administered as an intravenous (IV) infusion.
Administered as an IV infusion.
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Clinically significant changes in safety assessments (vital signs, electrocardiograms \[ECGs\], and clinical laboratory tests) are to be reported as adverse events.
Time frame: Up to approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Clinically significant changes in safety assessments (vital signs, ECGs, and clinical laboratory tests) are to be reported as adverse events.
Time frame: Up to approximately 3 years
Maximum Concentration (Cmax) of AMG 410
Time frame: Up to 85 days
Time to Reach Cmax (Tmax) of AMG 410
Time frame: Up to 85 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 410
Time frame: Up to 85 days
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 3 years
Clinical Benefit per RECIST v1.1
Time frame: Up to approximately 3 years
Duration of Response (DoR) per RECIST v1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Food Effect Substudy Cohort: Cmax of AMG 410 in the Fed and/or Fasted State
Time frame: Up to 24 days
Food Effect Substudy Cohort: Tmax of AMG 410 in the Fed and/or Fasted State
Time frame: Up to 24 days
Food Effect Substudy Cohort: AUC Over the Dosing Interval of AMG 410 in the Fed and/or Fasted State
Time frame: Up to 24 days
Change From Baseline in Tumor Phosphorylated Extracellular Signal Regulated Kinase (pERK)
Time frame: Baseline up to approximately 3 years
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
Amgen