KRAS Altered Advanced or Metastatic Solid TumorsPhase 1NCT07094113
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
A Phase 1 study testing AMG 410, Pembrolizumab and Panitumumab in people with KRAS Altered Advanced or Metastatic Solid Tumors, run by Amgen at 39 sites in 14 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS Altered Advanced or Metastatic Solid Tumors
- What is being tested?
- AMG 410, Pembrolizumab and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 39 sitesin 14 countries
- Study dates
- 31 Jul 2025to 20 Apr 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Untreated symptomatic central nervous system or leptomeningeal metastases.
- Uncontrolled pleural effusion and/or ascites.
- History of other malignancy within the past 5 years.
- 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.
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
- Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.
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- History of solid organ transplant.
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.
- 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).
- 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 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.
Trial locations and contacts
39 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 14 countries
United States10 sites, 10 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Next Virginia
Fairfax, Virginia, 22031
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
- Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Next Oncology
San Antonio, Texas, 78229
- Recruiting
Siteman Cancer Center - Washington University
St Louis, Missouri, 63110
Australia3 sites, 3 recruiting
- Recruiting
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Canada3 sites, 3 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Recruiting
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400044
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
Italy3 sites, 3 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
- Recruiting
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, 37134
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08023
- Recruiting
Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
France2 sites, 2 recruiting
- Recruiting
Centre Leon Berard
Lyon, 69008
- Recruiting
Gustave Roussy
Villejuif, 94805
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Asan Medical Center
Seoul, 05505
United Kingdom2 sites, 2 recruiting
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
- Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
Germany1 site, 1 recruiting
- Recruiting
Universitaetsklinikum Essen
Essen, 45147
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
About this study
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
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.
Read the detailed description
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.
- Being tested
- AMG 410, Pembrolizumab, Panitumumab
- Keywords
- Non-small cell lung cancer, NSCLC, Colorectal cancer, CRC, Pancreatic ductal adenocarcinoma, PDAC, AMG 410
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 410Drug
Administered as an oral tablet.
PembrolizumabDrug
Administered as an intravenous (IV) infusion.
PanitumumabDrug
Administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Monotherapy Dose Exploration | Experimental | Participants will receive escalating doses of AMG 410. Receives: Drug: AMG 410 |
| Part 1: Food Effect Substudy Cohort | Experimental | A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions. Receives: Drug: AMG 410 |
| Part 1: China-specific Cohort | Experimental | Participants identified through regionally approved molecular KRAS testing will receive AMG 410. Receives: Drug: AMG 410 |
| Part 2: Monotherapy Dose Expansion | 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. Receives: Drug: AMG 410 |
| Part 3a: Combination Therapy Dose Exploration and Dose Expansion | Experimental | Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors. Receives: Drug: AMG 410; Drug: Pembrolizumab |
| Part 3b: Combination Therapy Dose Exploration and Dose Expansion | Experimental | Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC. Receives: Drug: AMG 410; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: 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.
Measured: 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.
Measured: Up to approximately 3 years
Secondary outcomes (13)
Maximum Concentration (Cmax) of AMG 410
Measured: Up to 85 days
Time to Reach Cmax (Tmax) of AMG 410
Measured: Up to 85 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 410
Measured: Up to 85 days
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to approximately 3 years
Clinical Benefit per RECIST v1.1
Measured: Up to approximately 3 years
Duration of Response (DoR) per RECIST v1.1
Measured: Up to approximately 3 years
Time to Response (TTR) per RECIST v1.1
Measured: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST v1.1
Measured: Up to approximately 3 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Food Effect Substudy Cohort: Cmax of AMG 410 in the Fed and/or Fasted State
Measured: Up to 24 days
Food Effect Substudy Cohort: Tmax of AMG 410 in the Fed and/or Fasted State
Measured: Up to 24 days
Food Effect Substudy Cohort: AUC Over the Dosing Interval of AMG 410 in the Fed and/or Fasted State
Measured: Up to 24 days
Change From Baseline in Tumor Phosphorylated Extracellular Signal Regulated Kinase (pERK)
Measured: Baseline up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start31 Jul 2025
- Primary completion18 Apr 2028 (estimated)
- Study completion20 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS Altered Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094113
- Sponsor's protocol ID
- 20240031
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07094113
- Acronym / sponsor ID
- 20240031
- Keywords
- Non-small cell lung cancer, NSCLC, Colorectal cancer, CRC, Pancreatic ductal adenocarcinoma, PDAC, AMG 410
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 18 Apr 2028 (estimated)
- Study completion
- 20 Apr 2031 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Monotherapy Dose Exploration | Experimental | Drug: AMG 410Participants will receive escalating doses of AMG 410. |
| Part 1: Food Effect Substudy Cohort | Experimental | Drug: AMG 410A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions. |
| Part 1: China-specific Cohort | Experimental | Drug: AMG 410Participants identified through regionally approved molecular KRAS testing will receive AMG 410. |
| Part 2: Monotherapy Dose Expansion | Experimental | Drug: AMG 410Monotherapy 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. |
| Part 3a: Combination Therapy Dose Exploration and Dose Expansion | Experimental | Drug: AMG 410, Drug: PembrolizumabPart 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors. |
| Part 3b: Combination Therapy Dose Exploration and Dose Expansion | Experimental | Drug: AMG 410, Drug: PanitumumabPart 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- Untreated symptomatic central nervous system or leptomeningeal metastases.
- Uncontrolled pleural effusion and/or ascites.
- History of other malignancy within the past 5 years.
- 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.
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 410Administered as an oral tablet. | Drug | Part 1: China-specific Cohort, Part 1: Food Effect Substudy Cohort, Part 1: Monotherapy Dose Exploration, Part 2: Monotherapy Dose Expansion, Part 3a: Combination Therapy Dose Exploration and Dose Expansion, Part 3b: Combination Therapy Dose Exploration and Dose Expansion |
| PembrolizumabAdministered as an intravenous (IV) infusion. | Drug | Part 3a: Combination Therapy Dose Exploration and Dose Expansion |
| PanitumumabAdministered as an IV infusion. | Drug | Part 3b: Combination Therapy Dose Exploration and Dose Expansion |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Clinically significant changes in safety assessments (vital signs, electrocardiograms [ECGs], and clinical laboratory tests) are to be reported as adverse events.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately 3 years
Clinically significant changes in safety assessments (vital signs, ECGs, and clinical laboratory tests) are to be reported as adverse events.
13 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
39 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 410, Pembrolizumab and Panitumumab in people with KRAS Altered Advanced or Metastatic Solid Tumors, run by Amgen at 39 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Australia, Canada, China, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.