The FUZE Clinical Trial is evaluating an oral investigational medicinal product, called Debio 1347 Definition Debio 1347 is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways . Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in several in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic.Discover more .
The FGFR genes Definition a gene is like a blueprint defining what a cell should look like (placed in the DNA) provide instructions for making proteins called fibroblast growth factor receptors (FGFRs). These proteins play a role in important cellular processes. The presence of a specific alteration of the FGFR genes Definition a gene is like a blueprint defining what a cell should look like – called a fusion – induces the presence of altered receptors and may be associated with tumor cells growth. Debio 1347 Definition Debio 1347 is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways . Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in several in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic.Discover more is specifically targeted against these altered receptors.
The FUZE trial is a Phase II trial in adult male and female patients with advanced or metastatic tumors whose cells show specific FGFR gene alterations, namely FGFR1, FGFR2 or FGFR3 gene fusions. To be eligible, patients must require therapy and have radiologic and/or clinical progression following at least one prior standard treatment or have no satisfactory alternative treatment options. In this trial, biliary tract cancer (such as cholangiocarcinoma), urothelial cancer (such as bladder cancer) and other solid tumors (such as lung cancer, head and neck cancer, breast cancer, endometrial cancer, colon cancer and others) are being studied. Patients with primary brain tumors cannot enter this trial.
The purpose of the trial is to assess whether Debio 1347 Definition Debio 1347 is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways . Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in several in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic.Discover more is able to target and inhibit these altered FGFR genes Definition a gene is like a blueprint defining what a cell should look like and thereby facilitate cancer cell death and shrinkage of the tumor.
Patients will be recruited in North America, Europe, South America and the Asia Pacific region.

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Debiopharm International is conducting an open-label two-part Phase 1b/2 trial in male and female patients with either small cell lung cancer, squamous cell carcinoma of the head and neck, selected gastrointestinal or gynecologic cancers with specific genetic alterations. Tumors with these genetic alterations may respond better to this study treatment. To be eligible, patients must have received at least one prior standard chemotherapy or have no established standard therapeutic alternatives. In addition, patients must have progressed during prior immuno-oncology treatment.

The purpose of Part B is to evaluate whether Debio 1143 combined with nivolumab leads to efficient shrinkage of the tumor in patients with different types of cancer and to determine how safe it is.

Debio 1143 is an investigational medicinal product. Nivolumab is a monoclonal antibody that specifically blocks a target in the body called PD-1 and stimulates the immune system to fight cancer cells.

Debio 1143 is administered orally once daily for 10 consecutive days every 2 weeks. Nivolumab is administered by infusion every 2 weeks.

Debiopharm International is conducting the second part of a Phase I trial in male and female patients with advanced solid tumor malignancies, whose tumor cells show an alteration of specific genes Definition a gene is like a blueprint defining what a cell should look like (FGFR1, 2 or 3 genes Definition a gene is like a blueprint defining what a cell should look like ) and for whom standard treatment does not exist or is not indicated.

The presence of altered genes Definition a gene is like a blueprint defining what a cell should look like in these solid tumors may help the tumor cells to grow via receptors called fibroblast growth factor receptors 1, 2 and 3 on their surface. Debio 1347 Definition Debio 1347 is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways . Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in several in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic. More info: http://bit.ly/2xHPMKb , the investigational medicinal product that is tested in this trial, is specifically targeted against these receptors. The purpose of second part of the trial is to confirm the safety profile at the proposed Recommended Dose.

The patients are treated with Debio 1347 Definition Debio 1347 is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways . Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in several in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic. More info: http://bit.ly/2xHPMKb oral tablets daily in 28-day cycles until disease progression or until treatment discontinuation is required for other reasons.

In a first part of this trial, the highest dose of Debio 1347 Definition Debio 1347 is an orally available small molecule targeting FGFR 1, 2, 3 signaling pathways . Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in several in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic. More info: http://bit.ly/2xHPMKb that could be safely administered was determined. This information was needed to start the second part of the trial described above.

Debiopharm International is conducting an open-label Definition An open-label trial means that no placebo is administered and that patients know what treatment they are given. two-part Phase I trial in male and female patients. Part A is enrolling patients with advanced solid malignancies and Part B is aimed at patients with advanced or metastatic non-small cell lung cancer having already received platinum-based therapy.

The purpose of Part A is to evaluate increasing doses of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK combined with avelumab in patients with various advanced solid malignancies to determine the best tolerated dose that can be given to patients in Part B with advanced or metastatic non-small cell lung cancer. Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is an investigational medicinal product. Avelumab is a monoclonal antibody (a type of protein) that specifically attaches and blocks a target in the body call PD-L1, thus preventing cancer cells to evade the host (or patient) normal immune response.

In Part A, Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is administered orally once daily for 10 consecutive days every 2 weeks. Avelumab is administered by infusion twice every cycle.