Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab

Inclusion Criteria:

- Documented advanced or metastatic cancer ineligible for standard therapies with one of
the following histologies

- Dose Escalation: non-small cell lung cancer, head and neck squamous cell
carcinoma, nasopharyngeal carcinoma, breast cancer, urothelial carcinoma, gastric
cancer, colorectal adenocarcinoma, esophageal carcinoma, cervical cancer, ovarian
cancer, classical Hodgkin lymphoma

- Dose Expansion: nasopharyngeal carcinoma, gastric cancer, EBV+ lymphoma, head and
neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer,
triple-negative breast cancer

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

- Evaluable disease at baseline (at least one measurable target lesion by imaging for
expansion cohorts)

- Tumor available for biopsy

Exclusion Criteria:

- History of allergy or severe hypersensitivity to biologic agents

- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior
immuno-oncology treatment

- Active autoimmune disease or serious autoimmune disease within past 2 years requiring
systemic therapy

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required
steroids, or symptoms of active pneumonitis

- Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior
allogeneic organ transplant

- Active graft-versus-host disease