Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer

NCT04822298 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 20180273
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

Brief Summary

This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

Conditions

Non-small Cell Lung Cancer; NSCLC

Keywords

AMG 160; Phase 1b

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT)

  DLT were defined as any adverse event (AE) with an onset within first 28 days following first dose of AMG 160 meeting pre-specified criteria unless clearly attributable to causes other than AMG 160 treatment.

  Day 1 to Day 28

• Number of Participants Who Experience One or More Treatment-emergent AE (TEAE)

  An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE is any AE that occurred on or after first dose of study treatment up to 30 days after the last dose or End of Study date or start of new anti-cancer therapy, whichever is earlier. A treatment-related TEAE is any TEAE that, per investigator review, has a reasonable possibility of being caused by the study treatment. Any abnormal vital signs measurement or clinical laboratory test result, including those that worsened from Baseline, that were considered clinically significant in the medical and scientific judgement of the investigator were reported as an AE.

  Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days

Secondary Outcomes (9)

• Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Median (min, max) time from first dose to end of study was 100 (94, 122) days

• Overall Survival (OS)

  Median (min, max) time from first dose to end of study was 100 (94, 122) days

• Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1

  Median (min, max) time from first dose to end of study was 100 (94, 122) days

• Clinical PFS Per Modified RECIST v1.1

  Median (min, max) time from first dose to end of study was 100 (94, 122) days

• Time to Response Per Modified RECIST v1.1

  Median (min, max) time from first dose to end of study was 100 (94, 122) days

Study Arms (3)

Part 1: Dose Exploration

EXPERIMENTAL

The dose exploration part of the study will estimate the MTD and/or the RP2D.

Drug: AMG 160

Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC

EXPERIMENTAL

Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.

Drug: AMG 160

Part 2: Dose Expansion - Cohort 2 Squamous NSCLC

EXPERIMENTAL

Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.

Drug: AMG 160

Interventions

AMG 160 DRUG

AMG 160 administered as an intravenous (IV) infusion

Part 1: Dose Exploration; Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC; Part 2: Dose Expansion - Cohort 2 Squamous NSCLC

Eligibility Criteria

• Age: 18 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.
• Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
• Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
• With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
• Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
• Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.

You may not qualify if:

• Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
• Untreated or symptomatic brain metastases and leptomeningeal disease.
• History of hemoptysis within 3 months prior to first dose.
• History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
• Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months prior to start of dosing.
• Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
• Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
• Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
• Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
• Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
• Any biological therapy or immunotherapy within 3 weeks of start of first dose.
• Major surgery within 4 weeks of first dose.
• Infection requiring IV antimicrobials for management within 7 days of dosing.
• Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
• Active autoimmune disease

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Landeskrankenhaus Salzburg

Salzburg, 5020, Austria

Location

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: March 26, 2021
• First Posted: March 30, 2021
• Study Start: August 31, 2021
• Primary Completion: December 8, 2021
• Study Completion: January 26, 2022
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-01

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

AU (2); US (1)