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AMG 404 in Patients With Advanced Solid Tumors.

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ClinicalTrials.gov Identifier: NCT03853109
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AMG 404 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 404, a Programmed Death-1 (PD-1) Antibody, in Patients With Advanced Solid Tumors
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : August 22, 2021
Estimated Study Completion Date : August 22, 2021

Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1
Drug: AMG 404
AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.

Experimental: Cohort 2
Cohort 2
Drug: AMG 404
AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.

Experimental: Cohort 3
Cohort 3
Drug: AMG 404
AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.

Experimental: Cohort 4
Cohort 4
Drug: AMG 404
AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.




Primary Outcome Measures :
  1. Subject incidence of Dose limiting toxicities (DLTs) [ Time Frame: 28 Days ]
    Dose limiting toxicities (DLTs)

  2. Subject incidence of treatment emergent adverse events [ Time Frame: 28 Days ]
  3. Subject incidence of treatment related adverse events [ Time Frame: 28 Days ]
  4. Subject incidence of changes in vital signs [ Time Frame: 28 Days ]
  5. Subject incidence of clinical laboratory tests [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. QT interval relationship [ Time Frame: 24 months ]
    Evaluate relationship between QT interval and AMG 404 exposure

  2. Subject incidence of anti-AMG 404 antibodies [ Time Frame: 24 months ]
    Assess immunogenicity

  3. Maximum observed concentration (Cmax) of AMG 404 [ Time Frame: 24 months ]
    Pharmacokinetic (PK) analysis of AMG 404

  4. Time of maximum observed concentration (Tmax) of AMG 404 [ Time Frame: 24 months ]
    Pharmacokinetic (PK) analysis of AMG 404

  5. Area under the serum concentration-time curve (AUC) of AMG 404 [ Time Frame: 24 months ]
    Pharmacokinetic (PK) analysis of AMG 404



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age greater than or equal to 18 years old at the time of signing informed consent.
  • Life expectancy of greater than 3 months, in the opinion of the investigator
  • Subject must have histologically or cytologically confirmed 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 or is not available, or, In the investigator's opinion, standard therapy does not result in meaningful clinical benefit.
  • At least 1 measurable or evaluable lesion as defined by RECIST 1.1 guidelines.
  • Subjects with treated brain metastases are eligible provided they meet the following criteria: Definitive therapy was completed at least 2 weeks prior to enrollment. No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
  • Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.
  • Hematologic function, as follows without growth factor support within 2 weeks prior to study day 1: Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10E9/L; Platelet count greater than or equal to 75 x 10E9/L; Hemoglobin greater than or equal to 9 g/dL (90 g/L).
  • Adequate renal laboratory assessments, as follows: Estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation greater than or equal to 60 ml/min/1.73 m2.
  • Hepatic function, as follows: Total bilirubin less than or equal to 1.5 x ULN or less than or equal to 3 x ULN for subjects with liver metástasis; AST less than or equal to 3 x ULN or less than or equal to' 5 x ULN for subjects with liver metástasis; ALT less than or equal to 3 x ULN or less than or equal to 5 x ULN for subjects with liver metástasis; lkaline phosphatase less than or equal to 2.5 x ULN or less than or equal to 5 x ULN for subjects with liver metastasis.

Exclusion Criteria:

  • Disease Related. Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease
  • Other Medical Conditions. History of other malignancy within the past 2 years, with the following exception[s]: Malignancy treated with curative intent and with no known active disease present for greater than or equal to 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.
  • Prior/Concomitant Therapy: Prior treatment with anti-programmed death 1 (PD-1), anti-PD-L1, CTLA-4 or other checkpoint inhibitor drugs.
  • Anti-tumor therapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 21 days prior to study day 1. Note: Palliative radiotherapy is permitted.
  • Live vaccine therapy within 4 weeks prior to study drug administration.
  • Current treatment or within 14 days of day 1 with immunosuppressive corticosteroid defined as greater than 10 mg prednisone daily or equivalent. Corticosteroids with no or minimal systemic effect (such as topical or inhalation) are permitted.
  • Prior/Concurrent Clinical Study Experience: Currently receiving treatment in another investigational device or drug study, or ess than 21 days prior to study day 1 since ending treatment on another investigational device or drug study(ies).
  • Diagnostic Assessments: Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • 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.
  • History of allergic reactions or acute hypersensitivity reaction to antibody therapies.
  • Positive test for Human Immunodeficiency Virus (HIV).
  • Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). Negative HBsAg and positive for hepatitis B core antibody: Hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
  • Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
  • Active infection requiring systemic therapy.
  • Active or history of any autoimmune disease or immunodeficiencies. Subjects with Type I diabetes, vitiligo, psoriasis, hypo- or hyper- thyroid disease not requiring immunosuppressive treatment are permitted.
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association greater than class II), unstable angina, or cardiac arrhythmia requiring medication.
  • Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common herminology Criteria for Adverse Events (CTCAE) versión 5.0 grade 1, or are stable and well controlled with minimal, local, or non-invasive intervention AND there is agreement to allow by both the investigator and the Amgen Medical Monitor.

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): NCT03853109


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
Santa Monica, California, United States, 90403
United States, Colorado
Research Site Recruiting
Denver, Colorado, United States, 80218
United States, Kentucky
Research Site Recruiting
Louisville, Kentucky, United States, 40202
United States, North Carolina
Research Site Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Australia, South Australia
Research Site Recruiting
Woodville South, South Australia, Australia, 5011
Belgium
Research Site Recruiting
Edegem, Belgium, 2650
Poland
Research Site Recruiting
Warszawa, Poland, 02-781
United Kingdom
Research Site Recruiting
London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03853109     History of Changes
Other Study ID Numbers: 20180143
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
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 link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No