Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer

Status: Active

Description

A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

  • Age 18 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):
  • Part A: RR SCLC who progressed or recurred following platinum-based chemotherapy; Note: Subjects with a diagnosis of combined small cell carcinoma with >50% small cells may be considered for inclusion in the dose escalation phase of part A based on investigator discretion and after discussion with the medical monitor
  • Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following no more than 6 cycles of first-line platinum-based chemotherapy with the last dose of chemotherapy greater then equal to 28 days prior to the study day 1 (first-line consolidation setting)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Minimum life expectancy of 12 weeks
  • Indication A only: at least 2 measurable lesions as defined per modified RECIST 1.1 within 28 days prior to the first dose of AMG 757
  • Subjects with treated brain metastases are eligible provided they meet the following criteria:
  • Definitive therapy was completed at least 2 weeks prior to the first dose of AMG
  • - There is 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 pseudo progression 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.

Exclusion Criteria

  • History of other malignancy within the past 2 years prior to first dose of AMG 757 except:
  • Malignancy (other than in situ) treated with curative intent and with no known active disease present for 2 years before first dose of AMG 757 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
  • Major surgery within 28 days of first dose AMG 757
  • Untreated or symptomatic brain metastases and leptomeningeal disease
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757
  • Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757 Exceptions:
  • Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade .1
  • Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
  • Subjects who experienced immune related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immuno-oncology agents
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757
  • Live vaccination is not allowed for at least 4 weeks prior to the start of AMG 757 treatment, during treatment, and until end of last study dose

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 administered as a short term intravenous (IV) infusion in subjects with small cell lung cancer. AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Amgen, Inc.

Trial IDs

Primary ID 20160323
Secondary IDs NCI-2017-02043
Clinicaltrials.gov ID NCT03319940