First-In-Human Study of EOS884448 in Participants with Advanced Cancers.

Multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. The study will consist in a dose-escalation phase to determine the MTD, the RP2D, and the safety of EOS884448 in participants with advanced cancers.

Inclusion criteria

• Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448
• Be more than18 years of age on day of signing informed consent.
• Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available
• Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated
• Have an ECOG performance status of Grade 0 to 1.
• Have adequate organ function.
• Agree to use adequate contraception during the treatment if required.

Exclusion criteria

• Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose.
• Has undergone major surgery within 5 weeks before initiating treatment.
• Has received prior radiotherapy within 2 weeks of start of IP.
• Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible.
• Has known CNS metastases.
• Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids.
• Has uncontrolled or significant cardiovascular disease.
• Has received vaccine containing live virus within 4 weeks.
• Has known active or chronic viral hepatitis.
• Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.