A Phase 1b/2 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
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Krishnan, Mridula
Contact Information:
Olivia Loh
oloh@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06360354?term=NCT06360354&rank=1#participation-criteria
Summary
Primary Objectives:
-To determine maximum tolerated dose (MTD) or recommended combination dose of AMG 193 administered in combination with other therapies in adult subjects with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
-To determine the safety profile of AMG 193 administered in combination with other therapies in adult subjects with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
Secondary Objectives:
-To evaluate the anti-tumor activity of AMG 193 administered in combination with other therapies in adult subjects with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
-To characterize the pharmacokinetics (PK) of AMG 193 administered in combination with other therapies in adult subjects with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
Exploratory Objectives:
- To investigate biomarkers associated with clinical response. -To investigate molecular mechanisms of resistance to AMG 193.