A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

Description

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).

Conditions

MTAP-deleted NSCLC

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Study Overview

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Study Details

Study overview

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).

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)

A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

Condition
MTAP-deleted NSCLC
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Duarte

City of Hope Orange County Lennar Foundation Cancer Center, Duarte, California, United States, 91010

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Norwich

Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States, 06360

Ann Arbor

Trinity Health Saint Joseph Mercy Ann Arbor, Ann Arbor, Michigan, United States, 48106

Grand Rapids

Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States, 49503

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2029-02-19