A Dose Escalation, Expansion Study of Vofatamab (B-701) Alone, Plus Docetaxel, or Versus Docetaxel in Subjects With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Relapsed After, or Are Refractory to Standard Therapy
Condition: Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02401542
Sponsor: Rainier Therapeutics
Phase: Phase 1/Phase 2
- Age: minimum 18 Years maximum N/A
- Gender: All
- Stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or TCC arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
- Histological or cytological diagnosis of UCC.
- Relapsed after or are refractory to at least one prior line of chemotherapy which has not included a taxane (with the exception of Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion of Phase 2b which will allow the enrollment of patients with prior treatment with a taxane)
- Subjects must have received at least one prior chemotherapeutic regimen (at least one cycle each) for advanced or metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated).
- Prior neoadjuvant or adjuvant chemotherapy (without a taxane, except Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion, which will allow the enrollment of subjects with prior treatment with a taxane) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Phase 2 and Phase 2b Specific Inclusion Criteria:
- Patient must be confirmed to have a FGFR3 genomic alteration at the time of documentation of advanced disease.
- Relapsed after or are refractory to an immune checkpoint inhibitor. This inclusion criterion does not apply if the checkpoint inhibitor is contraindicated. Main
- Prior anti-cancer therapy within 2 weeks prior to Cycle 1, Day 1
- Prior treatment with an inhibitor that is targeted primarily to FGFRs
- Clinically significant comorbid medical conditions or lab abnormalities
- History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months
- History of clinically significant coagulation or platelet disorder in the past 12 months
- Currently receiving anticoagulation treatment
- Incomplete healing from wounds from prior surgery
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening
- Presence of positive test results for Hepatitis B or Hepatitis C
- Known history of human immunodeficiency virus (HIV) seropositive status
View trial on ClinicalTrials.gov