Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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

Keywords

Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, Advanced Cancer, Methylthioadenosine Phosphorylase, AMG 193, Oncology, Pancreatic Neoplasms, Paclitaxel, Gemcitabine, Folfirinox, Nab-paclitaxel, Modified FOLFIRINOX

Eligibility

For people ages 18-100

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.

Locations

  • Translational Research in Oncology US Inc, Trio Central Pharmacy accepting new patients
    Los Angeles California 90095 United States
  • University of California Los Angeles accepting new patients
    Santa Monica California 90404 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT06360354
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 188 study participants
Last Updated