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 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 effectiveness of GEN1042 combined with radiotherapy, with or without pembrolizumab, in treating metastatic solid tumors. This research is significant as it explores new treatment combinations for challenging cancer types.
The study tests two experimental interventions: Radiotherapy combined with GEN1042, and Radiotherapy combined with GEN1042 and Pembrolizumab. GEN1042 and Pembrolizumab are administered intravenously, and the treatments aim to enhance antitumor activity.
The study design includes two parts: a dose-finding phase and a randomized phase. In Part 1, participants receive treatments sequentially to determine safe doses, while Part 2 involves randomization to compare the efficacy of the treatment combinations. The study is open-label, meaning no masking is involved, and its primary purpose is treatment-focused.
The study began on March 8, 2023, with a primary completion date yet to be announced. The latest update was submitted on July 7, 2025. These dates are crucial as they mark the study’s progress and the timeline for potential results.
This study update could influence Genmab and BioNTech SE’s stock performance by potentially boosting investor confidence if the results show promise in treating metastatic solid tumors. The competitive landscape in cancer treatment is intense, and successful outcomes could position these companies favorably against peers.
The study is ongoing, with further details available on the ClinicalTrials portal.