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 collaborating on a clinical study titled ‘A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors.’ The study aims to assess the safety and efficacy of combining GEN1042 with radiotherapy, with or without pembrolizumab, for treating metastatic solid tumors. This trial is significant as it explores new treatment combinations that could potentially improve outcomes for patients with advanced cancer.
The interventions being tested include GEN1042, a biological agent administered intravenously, and radiotherapy, with the addition of pembrolizumab in one of the treatment arms. These combinations are designed to enhance the antitumor response in patients.
The study is interventional and involves two phases: a dose-finding phase (Part 1) and a randomized phase (Part 2). In Part 1, participants receive treatments sequentially to determine the optimal dose. In Part 2, participants are randomized into two groups to evaluate the efficacy of the treatment combinations. There is no masking involved, and the primary purpose is treatment.
The study began on March 8, 2023, marking the start of patient enrollment. The primary completion date is yet to be determined, but the last update was submitted on August 4, 2025. These dates are crucial for tracking the progress and potential availability of results.
This clinical study update could influence the stock performance of Genmab and BioNTech SE by potentially increasing investor confidence if the results show positive outcomes. The study’s progress also positions these companies competitively within the oncology treatment market, where innovative therapies are in high demand.
The study is ongoing, and further details are available on the ClinicalTrials portal.