Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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Amgen Inc. has launched a Phase 1b clinical study titled ‘AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)’. The study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AMG 193, a MTA-cooperative PRMT5 inhibitor, alone or combined with other therapies in patients with advanced thoracic tumors. This study is significant as it targets MTAP-deleted tumors, which are challenging to treat and have limited therapeutic options.
The study tests AMG 193, administered orally, both alone and in combination with other drugs like carboplatin, paclitaxel, pembrolizumab, pemetrexed, and sotorasib. These combinations aim to enhance treatment efficacy for patients with specific genetic mutations and tumor characteristics.
This interventional study employs a non-randomized, parallel assignment model without masking, focusing primarily on treatment. It is designed to determine the maximum tolerated dose and recommended combination dose of AMG 193, alongside its safety profile.
The study began on September 17, 2024, with its primary completion and estimated completion dates yet to be announced. The last update was submitted on June 25, 2025, indicating ongoing progress and recruitment.
The outcome of this study could significantly influence Amgen’s stock performance and investor sentiment, given the potential breakthrough in treating MTAP-deleted thoracic tumors. This could also impact the competitive landscape, as advancements in targeted cancer therapies are highly sought after in the pharmaceutical industry.
The study is currently recruiting, with further details available on the ClinicalTrials portal.