Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).

Official Title

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

Keywords

MTAP-deleted NSCLC, Oncology, AMG 193, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18-99

  • Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
  • Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
  • Either an archival tissue sample or an archival block must be available.
  • Life expectancy of greater than 3 months, in the opinion of the investigator.
  • Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
  • Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

You CAN'T join if...

Disease Related

• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2), KRAS proto-oncogene (KRAS).

Other Medical Conditions

  • Major surgery within 28 days of study day 1.
  • Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • Valkyrie Clinical Trials
    Los Angeles California 90067 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States
  • City of Hope Orange County Lennar Foundation Cancer Center
    Duarte California 91010 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT06593522
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated