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Clinical Trial 19723

Cancer Type: Thoracic
Interventions:AMG 119

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer

Summary

Objective

Primary Objective: Evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) Determine the maximum tolerated cell dose (MTCD) or recommended phase 2 cell dose (RP2CD) of AMG 119 Secondary Objectives: Evaluate preliminary evidence of anti-tumor activity of AMG 119 Evaluate expansion and persistence of AMG 119 post infusion Investigate evidence of AMG 119 trafficking to the tumor in post treatment biopsy

Inclusion Criteria

  • Over 18 years of age, and signed informed consent
  • Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:
  • 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 treated brain metastases are eligible provided they meet criteria outlined per protocol.
  • Adequate organ function
  • Other inclusion criteria may apply

  • Exclusion Criteria

  • History of other malignancy within the past 2 years prior to enrollment. Some exceptions apply.
  • 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 per protocol.
  • 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
  • Unresolved toxicities from prior anti-tumor therapy as defined per protocol.
  • Received live vaccine within 28 days prior to enrollment
  • Hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
  • 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 subject safety or interfere with the study evaluation, procedures or completion
  • Other exclusions may apply