A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT ID: NCT06131398
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
77 participants
INTERVENTIONAL
2024-03-07
2026-08-03
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Group A: AMG 355 monotherapy
Specified dose on specified days
AMG 355
Short-term intravenous (IV) infusion
Group B: AMG 355 and pembrolizumab
Specified dose on specified days
AMG 355
Short-term intravenous (IV) infusion
Pembrolizumab
Short-term IV infusion
Interventions
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AMG 355
Short-term intravenous (IV) infusion
Pembrolizumab
Short-term IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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City of Hope National Medical Center
Duarte, California, United States
Alliance for Multispecialty Research - Kansas City
Merriam, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
St Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Institut Bergonie
Bordeaux, , France
Gustave Roussy
Villejuif, , France
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Istituto Oncologico della Svizzera Italiana
Bellinzona, , Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20220028
Identifier Type: -
Identifier Source: org_study_id