A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

This is a Phase 1b/2 multi-center, open-label study to determine the safety, tolerability,
and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with
locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy
and who have not received prior immune checkpoint inhibitor or FGFR inhibitor-targeted
therapy. The study consists of 2 parts: a Phase 1b lead-in phase enrolling 6 to 18 subjects
and a Phase 2 dose expansion phase enrolling up to a total of 74 subjects.

Subjects who discontinue B-701 (vofatamab) may continue on study and receive pembrolizumab
alone until disease progression, death, withdrawal of patient consent, or study termination.
Subjects who discontinue pembrolizumab may continue on study and receive B-701 (vofatamab)
alone until disease progression, death, withdrawal of patient consent, or study termination.

Key Inclusion Criteria:

1. Have locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic
transitional cell carcinoma of the urothelium, including of the urinary bladder,
urethra, ureter, and/or renal pelvis. The diagnosis must be histologically or
cytologically confirmed.

2. Have progression during or following platinum-containing chemotherapy or within 12
months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

3. Have available archival tumor or be willing to undergo diagnostic biopsy at screening.
Sample must be of suitable quality and quantity to satisfy group assignment and
biomarker endpoints.

4. Have measurable disease according to Response Evaluation Criteria in Solid Tumors
Version 1.1 (RECIST v1.1).

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.

Key Exclusion Criteria:

1. Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia,
drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on
the Screening chest CT scan.

2. Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent,
or with an agent directed to another co-inhibitory T-cell receptor or FGFR inhibitor.

3. Patients with autoimmune disease or medical conditions that required systemic
corticosteroids (> 10 mg/day prednisone or its equivalent) or other immunosuppressive
medications or any other form of systemic immunosuppressive therapy within 7 days
prior to the first dose of study treatment. Note: Replacement therapy (e.g.
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,
etc.) is not considered a form of systemic treatment.

4. Primary central nervous system (CNS) malignancy or CNS metastases.

5. History of clinically significant coagulation or platelet disorder in the past 12
months.