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Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362748
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 23, 2020
First Posted Date  ICMJE April 27, 2020
Last Update Posted Date December 30, 2020
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date March 26, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2.5 Years ]
  • Number of Participants with Treatment-Related Adverse Events [ Time Frame: Up to 2.5 Years ]
  • Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement [ Time Frame: Up to 2 Years ]
  • Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Up to 2 Years ]
  • Maximum Tolerated Dose (MTD) of AMG 256 [ Time Frame: 28 days ]
  • Recommended Phase 2 Dose (RP2D) of AMG 256 [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • Maximum Observed Plasma Concentration (Cmax) of AMG 256 [ Time Frame: Up to 2.5 Years ]
  • Time to Achieve Cmax (Tmax) of AMG 256 [ Time Frame: Up to 2.5 Years ]
  • Area Under the Plasma Concentration-time Curve (AUC) of AMG 256 [ Time Frame: Up to 2.5 Years ]
  • Objective Response (OR) [ Time Frame: Up to 2.5 Years ]
  • Duration of Response (DOR) [ Time Frame: Up to 2.5 Years ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 1 Year ]
  • Disease Control Rate (DCR) [ Time Frame: Up to 2.5 Years ]
  • Duration of Stable Disease [ Time Frame: Up to 2.5 Years ]
  • Overall Survival (OS) [ Time Frame: Up to 2 Years ]
  • Number of Participants with anti-AMG 256 Antibodies [ Time Frame: Up to 2.5 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients With Advanced Solid Tumors
Brief Summary To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: AMG 256
AMG 256 administered as an intravenous (IV) infusion.
Study Arms  ICMJE
  • Experimental: Dose Escalation Phase
    Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.
    Intervention: Drug: AMG 256
  • Experimental: Dose Expansion Phase: Group 1
    Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
    Intervention: Drug: AMG 256
  • Experimental: Dose Expansion Phase: Group 2
    Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
    Intervention: Drug: AMG 256
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 23, 2025
Estimated Primary Completion Date March 26, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 years at the time of signing informed consent.
  • Life expectancy of > 3 months, in the opinion of the investigator.
  • Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which:
  • No standard therapy exists, or
  • Standard therapy has failed, not available, or
  • In the investigator's opinion, standard therapy does not result in meaningful clinical benefit.
  • 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.

Exclusion Criteria:

  • Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease.
  • History of other malignancy within the past 2 years, with the following Exceptions:
  • Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated cervical carcinoma in situ without evidence of disease.
  • Adequately treated breast ductal carcinoma in situ without evidence of disease.
  • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
  • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
  • History of solid organ transplantation.
  • Major surgery within 28 days of study day 1.
  • Live vaccine therapy within 4 weeks prior to study day 1.
  • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Active infection requiring oral or intravenous therapy.
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication.
  • History of severe allergic reactions or severe acute hypersensitivity reaction.
  • Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of AMG 256.
  • Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 3 months after the last dose of AMG 256.
  • Female participants of childbearing potential with a positive pregnancy test assessed within 48 hours prior to day 1 of treatment by a serum pregnancy test.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of AMG 256.
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of AMG 256.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of AMG 256.
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participants safety or interfere with the study evaluation, procedures or completion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04362748
Other Study ID Numbers  ICMJE 20180144
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP