Clinical Trials /

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

NCT04362748

Description:

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).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
  • Official Title: A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 20180144
  • NCT ID: NCT04362748

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
AMG 256Dose Escalation Phase

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation PhaseExperimentalDetermine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.
  • AMG 256
Dose Expansion Phase: Group 1ExperimentalParticipants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
  • AMG 256
Dose Expansion Phase: Group 2ExperimentalParticipants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
  • AMG 256

Eligibility 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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum Observed Plasma Concentration (Cmax) of AMG 256
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Time to Achieve Cmax (Tmax) of AMG 256
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Area Under the Plasma Concentration-time Curve (AUC) of AMG 256
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Objective Response (OR)
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
Time Frame:Up to 1 Year
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Duration of Stable Disease
Time Frame:Up to 2.5 Years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to 2 Years
Safety Issue:
Description:
Measure:Number of Participants with anti-AMG 256 Antibodies
Time Frame:Up to 2.5 Years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Last Updated

October 1, 2020