Daiichi Sankyo
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
Key Inclusion Criteria: The clinical site will screen for the full inclusion criteria per protocol. 1. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). 2. Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only). 3. Participants need to have documented TMB or MSI status using a validated or ap…
Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE. Dose Expansion Part: DS5361b will be administered at RDE.
Dose Escalation Part: Pembrolizumab will be administered at a standard dose. Dose Expansion Part: Pembrolizumab will be administered at a standard dose.