Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
NCT ID: NCT05800964
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
37 participants
INTERVENTIONAL
2023-06-13
2026-04-10
Brief Summary
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* Evaluate the safety and tolerability of AMG 305 in adult participants
* Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
* Determine the recommended phase 2 dose (RP2D)
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
TREATMENT
NONE
Study Groups
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Part A: Dose Exploration
Participants will receive escalating doses of AMG 305.
AMG 305
Short-term intravenous (IV) infusion
Part B: Dose Expansion
Participants with selected solid tumors will receive the RP2D identified in Part A.
AMG 305
Short-term intravenous (IV) infusion
Interventions
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AMG 305
Short-term intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* Male or female participants age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Participants with histologically or cytologically documented selected solid tumor diseases. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
* For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
* Life expectancy \> 3 months
* Adequate organ function
Exclusion Criteria
* History of other malignancy within the past 2 years
* Ongoing or active infection (including chronic or localized)
* Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring recurrent drainage procedures or other medical intervention within 2 weeks prior to the first dose of the investigational products.
* Known interstitial lung disease
* Positive test for human immunodeficiency virus (HIV)
* Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
* History of non-infectious/immune-checkpoint inhibitor related pneumonitis that required corticosteroids, or current or suspected pneumonitis that cannot be ruled out by imaging at screening.
* Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks of administration of the first dose of AMG 305; checkpoint inhibitor therapy within 3 months of the first dose of AMG 305; or other immunotherapies/monoclonal antibodies within 3 weeks of administration of the first dose of AMG 305.
* Has had a major surgery within 4 weeks of administration of a first dose of study treatment
* Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
* Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305
* Participants with unresolved toxicities from prior anti-tumor therapies to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or better, with the exception of alopecia and grade 2 peripheral neuropathy, which has been unchanged within the last 2 months and there is agreement to allow by both the investigator and sponsor
* Currently receiving treatment in another investigational device or drug study
* Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
* Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
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
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York University Cancer Institute
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Next Oncology
San Antonio, Texas, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Gustave Roussy
Villejuif, , France
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
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 12 de Octubre
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2022-502867-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20220073
Identifier Type: -
Identifier Source: org_study_id