FORT-2: Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab in urothelial carcinoma
Laufzeit: 01.01.2018 - 31.12.2022
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Kurzfassung
An international, multicenter, Phase1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab as first-line treatment in cisplatin-ineligible Patients with FGFR-positive locally advanced or metastatic urothelial carcinoma
Part A: Phase 1b
Primary objectives of Part A:
- To determine the safety and tolerability of rogaratinib in combination with atezolizumab in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma
- To determine the recommended Phase 2...
Part A: Phase 1b
Primary objectives of Part A:
- To determine the safety and tolerability of rogaratinib in combination with atezolizumab in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma
- To determine the recommended Phase 2 dose (RP2D) of rogaratinib in combination with atezolizumab in this patient population.
Secondary objective of Part A:
- To assess the efficacy of the combination of rogaratinib and atezolizumab in this patient population.
- To characterize the pharmacokinetics (PK) of rogaratinib in combination with atezolizumab in this patient population
Exploratory objectives of Part A:
- To assess new potential predictive or prognostic biomarkers and their association with tumor-related biomarkers, disease response, drug-resistance and patient outcome.
- To evaluate further biomarkers to investigate the drug (i.e. mode of-action-related effect and / or safety) and / or the pathomechanism of the disease.
- To evaluate the combination of rogaratinib and atezolizumab with regard to patient-reported outcomes (PRO)
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