The primary objectives of this trial are to: * Characterize the safety and tolerability of TEV-56278 * Determine the Recommended Phase 2 Dose (RP2D) * Evaluate antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab * Determine a RP2D of TEV-56278 in combination with pembrolizumab The secondary objectives of this trial are to: * Characterize the serum pharmacokinetics of TEV-56278 * Evaluate the antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 * Evaluate other measures of antitumor activity of TEV-56278 * Evaluate anti-tumor activity Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.
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Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Timeframe: Up to 15 months after 1st infusion in the escalation phase
Incidence of SAEs in the escalation phase
Timeframe: Up to 15 months after 1st infusion in the escalation phase
Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase
Timeframe: Up to 28 days after 1st infusion in the escalation phase
Incidence of dose modifications due to AEs in the escalation phase
Timeframe: Up to 12 months after 1st infusion in the escalation phase
Incidence of AEs leading to discontinuation in the escalation phase
Timeframe: Up to 12 months after 1st infusion in the escalation phase
Recommended Phase 2 dose as monotherapy
Timeframe: Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST criteria in the expansion phase
Timeframe: Up to 24 months after the 1st dose in the expansion phase
Duration of Response (DOR) in the expansion phase
Timeframe: Up to 24 months after the 1st dose in the expansion phase
Recommended Phase 2 dose in combination with Pembrolizumab
Timeframe: Up to 24 months after 1st dose
Incidence of AEs with CTCAE Grade≥3 in the combination phase
Timeframe: Up to 15 months after 1st infusion in the combination phase
Incidence of SAEs in the combination phase
Timeframe: Up to 15 months after 1st infusion in the combination phase
Incidence of AEs meeting protocol-defined DLT criteria in the combination phase
Timeframe: Up to 28 days after 1st infusion in the combination phase
Incidence of dose modifications due to AEs in the combination phase
Timeframe: Up to 12 months after 1st infusion in the combination phase
Incidence of AEs leading to discontinuation in the combination phase
Timeframe: Up to 12 months after 1st infusion in the combination phase