Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 1, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AMG 256 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients With Advanced Solid Tumors
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : November 27, 2023
Estimated Study Completion Date : August 27, 2025

Arm Intervention/treatment
Experimental: Dose Escalation Phase
Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.
Drug: AMG 256
AMG 256 administered as an intravenous (IV) infusion.

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.
Drug: AMG 256
AMG 256 administered as an intravenous (IV) infusion.

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.
Drug: AMG 256
AMG 256 administered as an intravenous (IV) infusion.




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2.5 Years ]
  3. Number of Participants with Treatment-Related Adverse Events [ Time Frame: Up to 2.5 Years ]
  4. Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement [ Time Frame: Up to 2 Years ]
  5. Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Up to 2 Years ]
  6. Maximum Tolerated Dose (MTD) of AMG 256 [ Time Frame: 28 days ]
  7. Recommended Phase 2 Dose (RP2D) of AMG 256 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of AMG 256 [ Time Frame: Up to 2.5 Years ]
  2. Time to Achieve Cmax (Tmax) of AMG 256 [ Time Frame: Up to 2.5 Years ]
  3. Area Under the Plasma Concentration-time Curve (AUC) of AMG 256 [ Time Frame: Up to 2.5 Years ]
  4. Objective Response (OR) [ Time Frame: Up to 2.5 Years ]
  5. Duration of Response (DOR) [ Time Frame: Up to 2.5 Years ]
  6. Progression-Free Survival (PFS) [ Time Frame: Up to 1 Year ]
  7. Disease Control Rate (DCR) [ Time Frame: Up to 2.5 Years ]
  8. Duration of Stable Disease [ Time Frame: Up to 2.5 Years ]
  9. Overall Survival (OS) [ Time Frame: Up to 2 Years ]
  10. Number of Participants with anti-AMG 256 Antibodies [ Time Frame: Up to 2.5 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362748


Contacts
Layout table for location contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Layout table for location information
United States, California
Research Site Recruiting
Duarte, California, United States, 91010
United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States, 46202
Australia, New South Wales
Research Site Recruiting
Camperdown, New South Wales, Australia, 02050
Research Site Recruiting
Darlinghurst, New South Wales, Australia, 02010
Australia, Victoria
Research Site Recruiting
Clayton, Victoria, Australia, 3168
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04362748    
Other Study ID Numbers: 20180144
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms