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).
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
Interventions
Drug | Synonyms | Arms |
---|
AMG 256 | | Dose 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
Name | Type | Description | Interventions |
---|
Dose Escalation Phase | Experimental | Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256. | |
Dose Expansion Phase: Group 1 | Experimental | Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study. | |
Dose Expansion Phase: Group 2 | Experimental | Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study. | |
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
June 3, 2021