Genmab (Otc) ((GMAB)), Biontech Se Sponsored Adr ((BNTX)), Biontech SE (($CC:BNTX.CUR)) announced an update on their ongoing clinical study.
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Genmab and BioNTech SE are conducting a pivotal clinical study titled ‘A First-in-Human, Open-label, Dose-finding Trial to Evaluate the Safety and Antitumor Activity of GEN1056 in Subjects With Advanced Solid Tumors.’ This study aims to assess the safety, optimal dosing, and preliminary antitumor efficacy of GEN1056 in patients with advanced solid tumors who have no standard treatment options. The trial’s significance lies in its potential to offer new therapeutic avenues for these patients.
The intervention being tested is GEN1056, a biological agent administered via intravenous infusion. Its primary purpose is to evaluate safety and antitumor activity, with the ultimate goal of determining the recommended dose and frequency for future studies.
This interventional study follows a sequential model with no masking, focusing primarily on treatment. It is designed to escalate doses in Part 1 to explore safety, followed by schedule optimization in Part 2 based on initial findings.
The study began on October 24, 2022, with an active, not recruiting status. The last update was submitted on July 7, 2025, indicating ongoing progress. These dates are crucial for tracking the study’s development and potential market entry timelines.
The study’s progress could significantly impact Genmab and BioNTech’s stock performance by enhancing investor confidence and market positioning, especially if GEN1056 proves effective. This development is noteworthy in the competitive landscape of cancer therapeutics, where innovation is key to gaining market share.
The study is ongoing, with further details available on the ClinicalTrials portal.