Astellas Pharma ((ALPMF)), Astellas Pharma ((ALPMY)) announced an update on their ongoing clinical study.
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Astellas Pharma is conducting a Phase 1 clinical study titled ‘A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation’. The study aims to evaluate the safety and tolerability of ASP3082 in adults with advanced solid tumors, focusing on those with the KRAS G12D mutation. This research is significant as it targets a specific genetic mutation, potentially leading to more effective treatments for patients with these challenging cancer types.
The study tests ASP3082, a drug administered via intravenous infusion, both as a monotherapy and in combination with other treatments like cetuximab, FOLFIRINOX, and pembrolizumab. The goal is to determine the appropriate dosage and assess the drug’s effectiveness in treating advanced solid tumors.
This open-label, non-randomized study follows a sequential intervention model with no masking, primarily aimed at treatment. It consists of two parts: dose escalation and dose expansion, to identify suitable doses for further testing.
The study began on June 8, 2022, with primary completion and estimated completion dates yet to be announced. The last update was submitted on June 30, 2025. These dates are crucial for tracking the study’s progress and anticipating future developments.
The outcome of this study could significantly impact Astellas Pharma’s stock performance and investor sentiment, as successful results may enhance the company’s portfolio in oncology. Given the competitive landscape in cancer treatment, advancements in targeting specific mutations like KRAS G12D could position Astellas favorably against competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.