A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andEfficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null SolidTumors
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The purpose of this study is to assess how the study drugs, AMG 193 and IDE397, move throughout the body, how the study drugs work in the body, whether they are safe, and an effective treatment option for people with advanced solid tumors lacking methylthioadeosine phosphorylase (MTAP) in the DNA (genetic material). Lacking MTAP may limit the way in which the enzyme, protein arginine methyltransferase 5 (PRMT5) works. PRMT5 is important for cancer cell survival and works with an enzyme methionine adenosyltransferase 2A (MAT2A). AMG193 may further slow down PRMT5 activity and kill cancer cells, and IDE397 may slow down MAT2A activity in cancer cells and kill them. The study drugs, AMG 193 and IDE397 are experimental drugs. Experimental means they have not been approved by any regulatory health agency such as the Food and Drug Administration [FDA].This is the first time AMG 193 in combination with IDE397 is being given to humans.
Are you Eligible? (Inclusion Criteria)
- You are ≥ 18 years of age 2. You have a minimum life expectancy of 12 weeks as per investigator judgment 3. You have advanced/metastatic solid tumor