A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAPnull Solid Tumors
Study of AMG 193 and IDE397 in Patients with Solid Tumors
Sponsor: Amgen
Enrolling: Male and Female Patients
IRB Number: AAAU8671
U.S. Govt. ID: NCT05975073
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: 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 methylthioadenosine 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. Cancer include: bladder cancer, breast cancer, colon and rectal cancer, esophageal cancer, gynecologic cancers, head and neck/oral cancer, kidney cancer, liver cancer, lung cancer, skin cancer, pancreatic cancer, prostate cancer, testicular cancer, and thyroid cancer.
Benjamin Herzberg, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with a solid tumor? Yes No
You may be eligible for this study

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