Name | Type | Description | Interventions |
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Part A: PY314 Single agent dose level 1 | Experimental | PY314 single agent dose level will depend on any safety signal observed in this cohorts only. Following the determination of the safety and tolerability of at least two PY314 dose levels by the safety review committee. | |
Part A: PY314 Single agent dose level 2 | Experimental | PY314 single agent dose level 2 dose escalation of PY314 as a single agent will continue in the absence of unacceptable dose limiting toxicity to the maximum administered dose as defined in the predefined dose escalation schema. | |
Part A: PY314 Single agent dose level 3 | Experimental | PY314 single agent dose level 3 to identify the maximum tolerated dose and/or to determine the recommended dose for expansion of PY314 | |
Part A: PY314 Single agent dose level 4 | Experimental | PY314 single agent dose level 4 to characterize the pharmacokinetic profile of PY314 as a single agent. | |
Part A: Combination dose level 1 | Experimental | Combination dose level 1 to characterize the safety and tolerability of PY314 as a single agent and in combination with pembrolizumab in subjects with advanced refractory solid tumors including refractory to check point inhibitor. | - Combination Therapy: PY314 + Pembrolizumab
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Part A: Combination dose level 2 | Experimental | PY314 combination dose level 2 to identify the maximum tolerated dose and/or to determine the recommended dose for expansion of PY314 administered alone and in combination with pembrolizumab. | - Combination Therapy: PY314 + Pembrolizumab
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Part A: Combination dose level 3 | Experimental | PY314 combination dose level 3 to characterize the pharmacokinetic profile of PY314 as a single agent and in combination with pembrolizumab. | - Combination Therapy: PY314 + Pembrolizumab
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Part A: Combination dose level 4 | Experimental | PY314 combination dose level 4 to describe, in subjects selected by pre-specified tumor histology, anti-tumor activity of PY314 administered alone and in combination with pembrolizumab. | - Combination Therapy: PY314 + Pembrolizumab
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Part B: Single agent dose expansion dose level 1 | Experimental | PY314 single agent dose expansion dose level 1 to define further the safety and tolerability of PY314 alone. | |
Part B: Single agent dose expansion dose level 2 | Experimental | PY314 single agent dose expansion dose level 2 to further characterize the PK profile of PY314 as a single agent. | |
Part B: Combination dose expansion cohort 1 | Experimental | PY314 in combination with pembrolizumab dose expansion cohort 1 to define the safety and tolerability of PY314 alone and in combination with pembrolizumab over multiple treatment cycles in subjects with pre-defined tumor histologies and confirmed TREM2 expression. | - Combination Therapy: PY314 + Pembrolizumab
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Part B: Combination dose expansion cohort 2 | Experimental | PY314 in combination with pembrolizumab dose expansion cohort 2 to further characterize the PK profile of PY314 as a single agent and in combination with pembrolizumab. | - Combination Therapy: PY314 + Pembrolizumab
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Part B: Combination dose expansion cohort 3 | Experimental | PY314 in combination with pembrolizumab dose expansion cohort 3 to characterize the anti-tumor activity of PY314 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM2 expression. | - Combination Therapy: PY314 + Pembrolizumab
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Part B: Combination dose expansion cohort 4 | Experimental | PY314 in combination with pembrolizumab dose expansion cohort 4 to evaluate the incidence of ADA formation and TREM2 expression. | - Combination Therapy: PY314 + Pembrolizumab
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