RECRUITING

A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.

Official Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion

Quick Facts

Study Start:2024-05-29
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06360354

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, 90095
United States
University of California Los Angeles
Santa Monica, California, 90404
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
United States
Hartford Hospital
Hartford, Connecticut, 06106
United States
Norwalk Hospital
Norwalk, Connecticut, 06856
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Norton Cancer Institute
Louisville, Kentucky, 40202
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Washington University
Saint Louis, Missouri, 63110
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Oncology Consultants Cancer Center
Houston, Texas, 77030
United States
US Oncology Research Investigational Products Center
Irving, Texas, 75063
United States
Virginia Cancer Specialists PC
Fairfax, Virginia, 22031
United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

  • Advanced Cancer
  • Methylthioadenosine Phosphorylase
  • AMG 193
  • Oncology

Additional Relevant MeSH Terms

  • Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers