A phase 1/1b/2 study evaluating the safety tolerability pharmacokinetics pharmacodynamics and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors

Brief description of study

The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null non-small cell lung cancer (NSCLC), after prior treatment with chemotherapy and/or a programmed death-1/ligand 1 (PD-1/L1) inhibitor.


Clinical Study Identifier: s22-00727
ClinicalTrials.gov Identifier: NCT05094336
Principal Investigator: Nina Beri.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Scot Niglio, Kirby Rodriguez, Janice Mehnert, Elise M Zahriah, Salman Rafi Punekar, Joshua K Sabari, Keriann M Scavone, Cosmin Adrian Tegla, Caitlin Elizabeth Ryan, Megan DiBenedetto, Eneil De La Pena, David R. Wise, Jessica Wang, Ann M Riccobene, Zujun Li, Amber M Lewis, Samantha VanMaanen, Kristen Spencer, Kathleen M Madden, Nancy Chan, Douglas K Marks.


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