A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Inclusion Criteria:

- Patient is at least 18 years of age

- Patient with advanced or metastatic solid tumor and has disease progression after
treatment who are intolerant to treatment that meets the following requirements for
the part of the study they will participate in:

1. Part 1: Patient with any advanced or metastatic solid tumor

2. Part 2A: Patient with any advanced or metastatic solid tumor

3. Part 2B: Patient with Non-Small Cell Lung Cancer (NSCLC), Endometrial cancers,
and MSI-H solid tumors.

- Female patients, if of childbearing potential, must have a negative serum pregnancy
test within 72 hours prior to the date of the first dose of study medication.

- Female patients of childbearing potential must agree to use 2 adequate methods of
contraception with their partner starting with the screening visit through 150 days
after the last dose of study therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 for Part 1 and ≤ 1
for Part 2. Adequate organ function.

Exclusion Criteria:

- Patient has received prior therapy with an anti- programmed death receptor 1
(anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD- L2)
agent.

- Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous
meningitis. Note: Patients with previously treated brain metastases may participate
provided they are stable (without evidence of progression by imaging for at least 4
weeks prior to the first dose of study treatment and any neurologic symptoms have
returned to baseline), have no evidence of new or enlarging brain metastases, and are
clinically stable off steroids for at least 7 days prior to study treatment.
Carcinomatous meningitis precludes a patient from study participation regardless of
clinical stability.

- Known additional malignancy that progressed or required active treatment within the
last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell
cancer (SqCC) of the skin that has undergone potentially curative therapy, or in situ
cervical cancer.

- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

- Known active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or
hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) (qualitative) is
detected).

- Active autoimmune disease that has required systemic treatment in the past 2 years
(ie, with use of disease- modifying agents, corticosteroids, or immunosuppressive
drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.

- History of interstitial lung disease.