Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

All participants:

Age ≥18 years;
Participants with histologically confirmed, locally advanced, unresectable, or metastatic solid tumors 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.

Expansion cohort only:

Histologically and/or cytologically confirmed recurrent/metastatic (R/M) SCCHN that is not amenable to curative therapy by surgery or radiation;
Only 1 prior anti-PD-1 or anti-PD-L1 therapy and documented PD-L1 scoring ≥1% by combined positive score or tumor proportion score as part of their treatment;
An anti-PD-1 or anti-PD-L1 treatment regimen must be the last prior therapy before study enrollment, following no more than 2 prior systemic regimens for R/M SCCHN;
Acquired resistance to an anti-PD-1- or anti-PD-L1-containing therapy;
The participant agrees to undergo a pre-treatment and on-treatment core or excisional biopsy and the biopsy procedure is not judged to be high risk by the Investigator.

Exclusion Criteria:

All participants:

Participant is deemed at high risk of fatal outcome in case of COVID-19;
Participants with a history of COVID-19 and have not provided a negative test for SARS CoV-2 infection within 28 days of the planned first dose date with FS118;
Prior therapy: Received systemic anti-cancer therapy within 28 days or 5 half-lives, of the first dose of study drug, or prior treatment with a LAG-3 inhibitor;
Participants 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 participants's participation in the study, as per the Investigator's judgment.

Expansion cohort only:

Participant has nasopharynx or thyroid primary tumor site;
History of severe immune-related toxicity during the prior treatment with checkpoint inhibitors.