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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07094113




Registration number
NCT07094113
Ethics application status
Date submitted
23/07/2025
Date registered
30/07/2025
Date last updated
28/08/2025

Titles & IDs
Public title
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
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
Secondary ID [1] 0 0
20240031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KRAS Altered Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 410
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Panitumumab

Experimental: Part 1: Monotherapy Dose Exploration - Participants will receive escalating doses of AMG 410.

Experimental: Part 1: Food Effect Substudy Cohort - A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions.

Experimental: Part 1: China-specific Cohort - Participants identified through regionally approved molecular KRAS testing will receive AMG 410.

Experimental: Part 2: Monotherapy Dose Expansion - 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.

Experimental: Part 3a: Combination Therapy Dose Exploration and Dose Expansion - Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors.

Experimental: Part 3b: Combination Therapy Dose Exploration and Dose Expansion - Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC.


Treatment: Drugs: AMG 410
Administered as an oral tablet.

Treatment: Drugs: Pembrolizumab
Administered as an intravenous (IV) infusion.

Treatment: Drugs: Panitumumab
Administered as an IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to approximately 3 years
Primary outcome [3] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Maximum Concentration (Cmax) of AMG 410
Timepoint [1] 0 0
Up to 85 days
Secondary outcome [2] 0 0
Time to Reach Cmax (Tmax) of AMG 410
Timepoint [2] 0 0
Up to 85 days
Secondary outcome [3] 0 0
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 410
Timepoint [3] 0 0
Up to 85 days
Secondary outcome [4] 0 0
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Clinical Benefit per RECIST v1.1
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Duration of Response (DoR) per RECIST v1.1
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Time to Response (TTR) per RECIST v1.1
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Progression-free Survival (PFS) per RECIST v1.1
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Food Effect Substudy Cohort: Cmax of AMG 410 in the Fed and/or Fasted State
Timepoint [10] 0 0
Up to 24 days
Secondary outcome [11] 0 0
Food Effect Substudy Cohort: Tmax of AMG 410 in the Fed and/or Fasted State
Timepoint [11] 0 0
Up to 24 days
Secondary outcome [12] 0 0
Food Effect Substudy Cohort: AUC Over the Dosing Interval of AMG 410 in the Fed and/or Fasted State
Timepoint [12] 0 0
Up to 24 days
Secondary outcome [13] 0 0
Change From Baseline in Tumor Phosphorylated Extracellular Signal Regulated Kinase (pERK)
Timepoint [13] 0 0
Baseline up to approximately 3 years

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/09/2030
Actual
Sample size
Target
434
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07094113