FORT-2: Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab in urothelial carcinoma

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 dose...

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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FORT-2: Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab in urothelial carcinoma

Kurzfassung

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