A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC

NCT03392064 | Suspended Phase 1 FDA Drug

• 1 other identifier: 20170124
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.

Conditions

Small Cell Lung Cancer

Keywords

AMG 119; CART; DLL3

Outcome Measures

Primary Outcomes (5)

• Incidence of dose limiting toxicities (DLTs)

  Up to 5 years

• Incidence of treatment-emergent adverse events and treatment-related adverse events

  Up to 5 years

• Incidence of clinically significant changes in vital signs

  Up to 5 years

• Incidence of clinically significant changes in physical examinations

  Up to 5 years

• Incidence of clinically significant changes in clinical laboratory tests

  Up to 5 years

Secondary Outcomes (7)

• Objective Response (OR)

  Up to 5 years

• Duration of Response (DOR)

  Up to 5 years

• Progression-Free Survival (PFS)

  Up to 5 years

• 1-year Overall Survival (1-year OS)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (1)

AMG 119 Treatment

EXPERIMENTAL

AMG 119 administered as a one-time intravenous infusion at different cell dose levels

Biological: AMG 119

Interventions

AMG 119 BIOLOGICAL

Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer

AMG 119 Treatment

Eligibility Criteria

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

You may qualify if:

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures;
• Age ≥ 18 years old at the time of signing the informed consent
• Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor
• 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 for at least 7 days.
• Adequate organ function

You may not qualify if:

• History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) 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 in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.
• History of organ transplant.
• Major surgery within 28 days of enrollment.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of enrollment.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.
• Untreated or symptomatic brain metastases and leptomeningeal disease
• Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.
• Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).
• Evidence of a bleeding diathesis.
• Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. ≥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.
• Prior anti-cancer therapy as specified below: At least 21 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy with the exception of subjects who received AMG 119 in this study and are eligible for retreatment.
• Primary immunodeficiency
• History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
• Received live vaccine within 28 days prior to enrollment
• Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C

Sponsors & Collaborators

• Amgen: lead

Study Sites (2)

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.

  PMID: 31215500 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: September 10, 2018
• Primary Completion (Estimated): January 14, 2028
• Study Completion (Estimated): January 14, 2028
• Last Updated: October 15, 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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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

US (2)