Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

NCT04362748 | Completed Phase 1 FDA Drug

• 1 other identifier: 20180144
• Study Type: interventional
• Target: 34
• Locations: 4 countries
• Sites: 11

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).

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (7)

• Number of Participants with Dose Limiting Toxicities (DLTs)

  28 days

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to 2.5 Years

• Number of Participants with Treatment-Related Adverse Events

  Up to 2.5 Years

• Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement

  Up to 2 Years

• Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests

  Up to 2 Years

• Maximum Tolerated Dose (MTD) of AMG 256

  28 days

• Recommended Phase 2 Dose (RP2D) of AMG 256

  28 days

Secondary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) of AMG 256

  Up to 2.5 Years

• Time to Achieve Cmax (Tmax) of AMG 256

  Up to 2.5 Years

• Area Under the Plasma Concentration-time Curve (AUC) of AMG 256

  Up to 2.5 Years

• Objective Response (OR)

  Up to 2.5 Years

• Duration of Response (DOR)

  Up to 2.5 Years

Study Arms (3)

Dose Escalation Phase

EXPERIMENTAL

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.

Drug: 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.

Drug: AMG 256

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.

Drug: AMG 256

Interventions

AMG 256 DRUG

AMG 256 administered as an intravenous (IV) infusion.

Dose Escalation Phase; Dose Expansion Phase: Group 1; Dose Expansion Phase: Group 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (11)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

St Vincents Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

• Kroenke MA, Starcevic Manning M, Zuch de Zafra CL, Zhang X, Cook KD, Archer M, Lolkema MP, Wang J, Hoofring S, Saini G, Aeffner F, Ahern E, Cabanas EG, Govindan R, Hui M, Gupta S, Mytych DT. Translatability of findings from cynomolgus monkey to human suggests a mechanistic role for IL-21 in promoting immunogenicity to an anti-PD-1/IL-21 mutein fusion protein. Front Immunol. 2024 Jan 26;15:1345473. doi: 10.3389/fimmu.2024.1345473. eCollection 2024.

  PMID: 38343535 BACKGROUND

Related Links

• AmgenTrials clinical trials website

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: September 15, 2020
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

BE (2); AU (3); US (4); ES (2)