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

Launched by AMGEN · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called AMG 193 for patients with advanced cancers of the gastrointestinal tract, biliary tract, or pancreas that have a specific genetic change known as homozygous MTAP-deletion. The main goal is to find out the highest safe dose of AMG 193 when used with other therapies and to understand how safe it is for patients. This study is currently looking for adult participants aged 18 and older who have been diagnosed with advanced pancreatic cancer that cannot be surgically removed.

To be eligible for this trial, participants must have a confirmed diagnosis of metastatic or locally advanced pancreatic cancer and have a specific type of tumor that meets certain criteria. They will need to provide a sample of their tumor tissue, either from previous tests or through a biopsy if necessary. Participants can expect close monitoring throughout the trial to assess how well the treatment is working and to check for any side effects. It's important to note that individuals who have received certain previous treatments or who have specific health conditions may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• • Subprotocol B
• Inclusion:
• • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
• • Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
• • Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
• • Homozygous MTAP-deletion.
• • Disease measurable as defined by RECIST v1.1.
• • Adequate organ function as defined in the protocol.
• Exclusion:
• • Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
• • Radiation therapy within 28 days of first dose.
• • Major surgery within 28 days of first dose of AMG 193.
• • Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
• • Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
• • History of solid organ transplantation.