Advanced Solid TumorsPhase 1NCT06131398
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
A Phase 1 study testing AMG 355 and Pembrolizumab in people with Advanced Solid Tumors, run by Amgen at 25 sites in 11 countries.
Trial summary
The primary objectives of this study are to: Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AMG 355 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 25 sitesin 11 countries
- Study dates
- 7 Mar 2024to 22 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of signing informed consent.
- Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with known clinical benefit at time of pre-screening:
- Group A: NSCLC, CRC, GC, and melanoma.
- Group B: NSCLC, CRC, GC.
- Eastern Cooperative Oncology Group Performance status 0 or 1.
- Life expectancy of > 3 months, in the opinion of the investigator.
Show all 11Show fewer
- At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note: this lesion should be avoided for the required biopsies on the study.
- Participants must be willing to undergo 1 or more biopsies as follows:
- Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not obtainable, an archival tumor sample may be acceptable if the sample was obtained within 6 months of enrollment and participant has not received any other treatment since sample was obtained, consult the Medical Monitor.
- Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of treatment with AMG 355 (± pembrolizumab).
- Note: Where slides are accepted, samples must consist of a minimum of 11 (21 preferred) freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded block is preferred if available, but in lieu of a block, unstained slides or fresh wet tissue is acceptable.
Who cannot join
- Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137), and was discontinued from that treatment due to an immune-related adverse events.
- Untreated or symptomatic brain metastases and leptomeningeal disease Note: participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Chronic intake of systemic corticosteroids (eg prednisone > 10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine or insulin) is not considered a form of systemic treatment and is allowed.
- History of organ transplantation.
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
25 sites in 11 countries.
25 sites in 11 countries
United States6 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope National Medical Center
Duarte, California, 91010
Alliance for Multispecialty Research - Kansas City
Merriam, Kansas, 66204
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Washington University
St Louis, Missouri, 63110
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Spain3 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08023
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital Universitario Ramon y Cajal
Madrid, 28034
Australia2 sites
St Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Japan2 sites
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Netherlands2 sites
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Erasmus Medisch Centrum
Rotterdam, 3015 CE
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 138-736
Switzerland2 sites
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Poland1 site
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781
About this study
Official title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
The primary objectives of this study are to:
- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors
- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- AMG 355, Pembrolizumab
- Keywords
- Advanced Solid Tumors, AMG 355, Pembrolizumab, Pharmacokinetics, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Gastric Cancer (GC), Melanoma (MEL)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Stomach Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 355Drug
Short-term intravenous (IV) infusion
PembrolizumabDrug
Also called Keytruda
Short-term IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A: AMG 355 monotherapy | Experimental | Specified dose on specified days Receives: Drug: AMG 355 |
| Group B: AMG 355 and pembrolizumab | Experimental | Specified dose on specified days Receives: Drug: AMG 355; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Measured: Day 1 to Day 21
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
Measured: Up to 2 years
Number of Participants Who Experience a Treatment-related AE
Measured: Up to 2 years
Secondary outcomes (10)
Maximum Observed Serum Concentration (Cmax) of AMG 355
Measured: Up to 85 days
Minimum Observed Serum Concentration (Cmin) of AMG 355
Measured: Up to 85 days
Area Under the Concentration-time Curve (AUC) of AMG 355
Measured: Up to 85 days
Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: Up to 2 years
Clinical Benefit per RECIST v1.1
Measured: Up to 2 years
Duration of Response per RECIST v1.1
Measured: Up to 2 years
Time to Progression by RECIST v1.1
Measured: Up to 2 years
Progression-free Survival (PFS) by RECIST v1.1
Measured: Up to 2 years
Overall Survival
Measured: Up to 2 years
Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start7 Mar 2024
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
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
- NCT06131398
- Sponsor's protocol ID
- 20220028
- Status last verified
- Aug 2026
- First submitted
- 9 Nov 2023
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06131398
- Acronym / sponsor ID
- 20220028
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, AMG 355, Pembrolizumab, Pharmacokinetics, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Gastric Cancer (GC), Melanoma (MEL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 14 Nov 2023 (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 primary objectives of this study are to:
- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors
- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: AMG 355 monotherapy | Experimental | Drug: AMG 355Specified dose on specified days |
| Group B: AMG 355 and pembrolizumab | Experimental | Drug: AMG 355, Drug: PembrolizumabSpecified dose on specified days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years at the time of signing informed consent.
- Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with known clinical benefit at time of pre-screening:
- Eastern Cooperative Oncology Group Performance status 0 or 1.
- Life expectancy of > 3 months, in the opinion of the investigator.
- At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note: this lesion should be avoided for the required biopsies on the study.
Key exclusion criteria (8 listed)
- Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137), and was discontinued from that treatment due to an immune-related adverse events.
- Untreated or symptomatic brain metastases and leptomeningeal disease Note: participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Chronic intake of systemic corticosteroids (eg prednisone > 10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine or insulin) is not considered a form of systemic treatment and is allowed.
- History of organ transplantation.
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 355Short-term intravenous (IV) infusion | Drug | Group A: AMG 355 monotherapy, Group B: AMG 355 and pembrolizumab |
| PembrolizumabAlso: KeytrudaShort-term IV infusion | Drug | Group B: AMG 355 and pembrolizumab |
Primary outcome
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Up to 2 years
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
Number of Participants Who Experience a Treatment-related AE
Time frame: Up to 2 years
10 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of AMG 355
Time frame: Up to 85 days
Minimum Observed Serum Concentration (Cmin) of AMG 355
Time frame: Up to 85 days
Area Under the Concentration-time Curve (AUC) of AMG 355
Time frame: Up to 85 days
Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Up to 2 years
Clinical Benefit per RECIST v1.1
Time frame: Up to 2 years
Duration of Response per RECIST v1.1
Time frame: Up to 2 years
Time to Progression by RECIST v1.1
Time frame: Up to 2 years
Progression-free Survival (PFS) by RECIST v1.1
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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. This study is not recruiting at the moment.
MD study director
Amgen
25 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 355 and Pembrolizumab in people with Advanced Solid Tumors, run by Amgen at 25 sites in 11 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, Australia, France, Japan and 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) (time frame: Day 1 to Day 21). 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 11 Aug 2026.