Clinical trial · Interventional
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Derazantinib 200 mg once daily + atezolizumab 1200 mg | Drug | — | UNRESOLVED |
| Derazantinib 200 mg twice daily + atezolizumab 1200 mg | Drug | — | UNRESOLVED |
| Derazantinib 200 mg twice daily monotherapy | Drug | — | UNRESOLVED |
| Derazantinib 300 mg once daily+ atezolizumab 1200 mg | Drug | — | UNRESOLVED |
| Derazantinib 300 mg once daily monotherapy | Drug | — | UNRESOLVED |
| Derazantinib 300 mg once daily monotherapy (QD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Substudy 1: Derazantinib 300 mg once daily
- description
- Patients with urothelial cancer were treated with derazantinib 300 mg once daily
- interventionNames
- Drug: Derazantinib 300 mg once daily monotherapy
- type
- EXPERIMENTAL
- label
- Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg
- description
- Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion
- interventionNames
- Drug: Derazantinib 200 mg once daily + atezolizumab 1200 mg
- type
- EXPERIMENTAL
- label
- Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract * Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease * Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on) * Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 * Adequate organ functions as indicated by Screening visit local laboratory values Exclusion Criteria: * Receipt of prior cancer treatment within specific interval periods * Concurrent evidence of any clinically significant corneal or retinal disorder * History of clinically significant cardiac disorders * Known CNS metastases * Concurrent uncontrolled or active infection with human immunodeficiency virus * Active hepatitis B or chronic hepatitis B without current antiviral therapy * Active hepatitis C * Active tuberculosis * Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration
References
Publications (1)
- DERIVEDNecchi A, Ramlau R, Falcon Gonzalez A, Chaudhry A, Todenhofer T, Tahbaz R, Fontana E, Giannatempo P, Deville JL, Pouessel D, Yoon S, Powles T, Bernat M, Hackl M, Marszewska M, McKernan P, Saulay M, Scaleia F, Engelhardt M, Loriot Y, Siefker-Radtke A, De Santis M. Derazantinib alone and with atezolizumab in metastatic urothelial carcinoma with activating FGFR aberrations. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae030. doi: 10.1093/jncics/pkae030. PMID 38627238