FS118 First in Human Study in Patients With Advanced Malignancies After PD-1/PD-L1 Containing Therapy

Inclusion Criteria:

- Age ≥18 years;

- Patients with histologically confirmed, locally advanced, unresectable, or metastatic
solid tumors or hematological malignancies that progressed while on or after
PD-1/PD-L1 containing therapy;

- Measurable disease;

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1;

- Life expectancy estimated to be at least 3 months;

- Highly effective contraception

- Willing and able to provide written informed consent.

Exclusion Criteria:

- Prior treatment with more than 1 checkpoint inhibitor (combination); prior treatment
with a lymphocyte-activation gene 3 (LAG-3) inhibitor; prior treatment with multi
specific checkpoint inhibitor molecules;

- Patients with active or documented history of autoimmune disease;

- History of uncontrolled intercurrent illness:

- Known infections:

- Uncontrolled CNS metastases, primary CNS tumors, or solid tumors with CNS metastases
as only measurable disease;

- Prior history of or active interstitial lung disease or pneumonitis, encephalitis,
seizures, severe immune related adverse events with prior PD-1/PD-L1 containing
treatments;

- Significant cardiac abnormalities;

- Significant laboratory abnormalities;

- Intolerance to the investigational product or its excipients, or any condition that
would significantly impair and/or prohibit the patient's participation in the study,
as per the Investigator's judgment.