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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05800964
Registration number
NCT05800964
Ethics application status
Date submitted
24/03/2023
Date registered
6/04/2023
Date last updated
8/05/2025
Titles & IDs
Public title
Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
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Scientific title
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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2022-502867-39
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Secondary ID [2]
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20220073
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 305
Experimental: Part A: Dose Exploration - Participants will receive escalating doses of AMG 305.
Experimental: Part B: Dose Expansion - Participants with selected solid tumors will receive the RP2D identified in Part A.
Treatment: Drugs: AMG 305
Short-term intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Day 1 to Day 28
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Primary outcome [2]
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Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to a maximum of 2 years
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Primary outcome [3]
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Percentage of Participants who Experience Treatment-Related Adverse Events
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Assessment method [3]
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Timepoint [3]
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Up to a maximum of 2 years
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Secondary outcome [1]
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Maximum Serum Concentration (Cmax) of AMG 305
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Assessment method [1]
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Timepoint [1]
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Up to a maximum of 2 years
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Secondary outcome [2]
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Minimum Serum Concentration (Cmin) of AMG 305
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Assessment method [2]
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Timepoint [2]
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Up to a maximum of 2 years
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Secondary outcome [3]
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Area Under the Concentration-Time Curve (AUC) of AMG 305
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Assessment method [3]
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Timepoint [3]
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Up to a maximum of 2 years
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Secondary outcome [4]
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Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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Assessment method [4]
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ORR is defined as best overall response (BOR) of complete response (CR) or partial response (PR), Clinical Benefit Rate (defined as BOR of CR, PR, or stable disease \[SD\] with duration of 24 weeks or longer) based on RECIST v1.1.
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Timepoint [4]
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Up to a maximum of 2 years
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Secondary outcome [5]
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ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
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Assessment method [5]
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ORR is defined as immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR), Clinical Benefit Rate (defined as iBOR of iCR, iPR, or immune stable disease \[iSD\] with duration of 24 weeks or longer) based on iRECIST.
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Timepoint [5]
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Up to a maximum of 2 years
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Secondary outcome [6]
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Duration of Response (DOR)
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Assessment method [6]
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DOR is defined as the time from the first documentation of objective response until the first documentation of disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
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Timepoint [6]
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Up to a maximum of 2 years
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Secondary outcome [7]
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Time to Progression
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Assessment method [7]
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Time to progression is defined as the time rom first AMG 305 dose until the first documentation of radiological disease progression by RECIST v1.1 and iRECIST.
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Timepoint [7]
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Up to a maximum of 2 years
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Secondary outcome [8]
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Progression-Free Survival (PFS)
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Assessment method [8]
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PFS is defined as the time from first AMG 305 dose until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
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Timepoint [8]
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Up to a maximum of 2 years
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Secondary outcome [9]
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Overall Survival (OS) at 1 Year
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Assessment method [9]
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Timepoint [9]
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1 year
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Secondary outcome [10]
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OS at 2 Years
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Assessment method [10]
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Timepoint [10]
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2 years
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Eligibility
Key inclusion criteria
Key
* Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures
* 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
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/02/2028
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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New Jersey
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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Canada
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State/province [7]
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Ontario
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Country [8]
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France
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State/province [8]
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Toulouse cedex 9
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Country [9]
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France
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State/province [9]
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Villejuif
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Country [10]
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Germany
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State/province [10]
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Dresden
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Germany
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State/province [11]
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Essen
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Germany
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State/province [12]
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Wuerzburg
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Japan
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Chiba
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Country [14]
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Korea, Republic of
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State/province [14]
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Seoul
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Country [15]
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Spain
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State/province [15]
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Cataluña
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Country [16]
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Spain
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State/province [16]
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Madrid
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United Kingdom
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State/province [17]
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Glasgow
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Country [18]
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United Kingdom
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State/province [18]
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London
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Country [19]
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United Kingdom
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State/province [19]
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Manchester
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Country [20]
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United Kingdom
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State/province [20]
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Newcastle
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Country [21]
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United Kingdom
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State/province [21]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to: * 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)
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Trial website
https://clinicaltrials.gov/study/NCT05800964
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amgen Call Center
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Address
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Country
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Phone
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866-572-6436
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT05800964
Download to PDF