A Phase 1 Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

Partial Inclusion Criteria:

- Patient with advanced or metastatic solid tumor and has disease progression or
treatment intolerance after treatment with available therapies

- Agreement to biopsies before and during treatment, depending on study part

- Female patients must have a negative pregnancy test or be of non-childbearing
potential.

- Required that female patients of childbearing potential use two methods of
contraception with their partner

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 with adequate
hematologic and organ function

Partial Exclusion Criteria:

- Received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD1-ligand-1 (anti-PD-L1)
or anti-PD-1 ligand-2 (anti-PD-L2) agent within 3 weeks prior to initiation of study
treatment depending on study part

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-TIM-3 or anti-LAG-3 (Part 1e)

- Prior treatment with an anti-LAG-3 or anti-TIM-3 (Part 2)

- Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous
meningitis or known malignancy that progressed or required active treatment within the
last 2 years

- Pregnant, breastfeeding, or expecting to conceive children within 150 days after the
last dose of study treatment

- History of human immunodeficiency virus (HIV), pneumonitis, active Hepatitis B or
Hepatitis C, or ≥Grade 3 immune-related AE with prior immunotherapy

- Autoimmune disease that required systemic treatment

- Not recovered from radiation and chemotherapy-induced AEs

- Participated in another investigational study (drug or device) within 4 weeks of first
dose

- Received prior anticancer therapy within 21 days of first dose

- Not recovered from AEs and/or complications from major surgery prior to first dose

- Received a vaccine within 7 days of first dose