NP-G2-044 Monotherapy Primary Objectives The primary objectives for patients receiving NP-G2-044 monotherapy are the following: - To identify the recommended Phase 2 dose (RP2D) of continuously dosed NP-G2-044 monotherapy (Mono-RP2D) and characterize its safety; and - To assess preliminary signals of NP-G2-044 anti-tumor efficacy when administered as continuously dosed monotherapy. NP-G2-044 Combination Therapy Primary Objectives The primary objectives for patients receiving NP-G2-044 in combination with anti-programmed death-1/programmed death ligand-1 (PD-[L]1) therapy are the following: - To determine the RP2D of NP-G2-044 administered in combination with anti-PD-(L)1 therapy (Combo-RP2D) and characterize its safety in patients who have initiated anti-PD-(L)1 therapy in accordance with the package insert and have been receiving the anti-PD-(L)1 therapy for 3 months (and therapy is currently ongoing) and have stable disease, or who had an initial period of stable disease and now have an initial scan demonstrating progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; - To assess preliminary signals of NP-G2-044 anti-tumor efficacy when administered in combination with anti-PD-(L)1 therapy in patients who have initiated anti-PD-(L)1 therapy in accordance with the package insert and have been receiving the anti-PD-(L)1 therapy for 3 months (and therapy is currently ongoing) and have stable disease, or who had an initial period of stable disease and now have an initial scan demonstrating progressive disease per RECIST 1.1. NP-G2-044 Monotherapy Primary Endpoints The primary endpoints for patients receiving NP-G2-044 monotherapy are the following: -To identify the Mono-RP2D; -To characterize the safety of continuously dosed NP-G2-044 monotherapy as determined by the incidence of TEAEs, incidence of DLTs, laboratory abnormalities, and other safety criteria using NCI CTCAE v5.0; and - To characterize preliminary signals of NP-G2-044 anti-tumor efficacy when administered as continuously dosed NP-G2-044 monotherapy by RECIST 1.1, including a description of the following: o Objective response rate (ORR); - ORR is defined as the number of patients who have a radiographically-confirmed complete response (CR) or partial response (PR) during the study. o Duration of response (DOR); - DOR is defined as the time from the first CR or PR (that is subsequently confirmed) to disease progression. o Disease control rate (DCR); - DCR is defined as the sum of the number of patients who have a radiographically-confirmed CR, PR, or stable disease during the study. o Progression-free survival (PFS); - PFS is defined as the time from first dose to disease progression or death from any cause. o Metastasis-free interval (MFI); and - MFI is defined as the time from first dose to documented new disease metastasis. o Time to tumor progression (TTP). NP-G2-044 Combination Therapy Primary Endpoints The primary endpoints for patients receiving NP-G2-044 in combination with anti-PD-(L)1 therapy are the following: - To define the Combo-RP2D; - To characterize the safety of NP-G2-044 in combination with anti-PD-(L)1 therapy as determined by the incidence of TEAEs, incidence of DLTs, laboratory abnormalities, and other safety criteria using NCI CTCAE v5.0; and - To characterize signals of NP-G2-044 anti-tumor efficacy when administered in combination with anti-PD-(L)1 therapy by RECIST 1.1, including a description of ORR, DOR, DCR, PFS, MFI, and TTP. Secondary Endpoint The secondary endpoint for patients receiving NP-G2-044 monotherapy is the following: - To further characterize the PK of continuously dosed NP-G2-044 monotherapy and make PK comparisons to discontinuously dosed NP-G2-044 monotherapy (as studied in the previous Phase 1A study). Secondary Endpoints The secondary endpoints for patients receiving NP-G2-044 in combination with ant

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: 99 years or below
• Gender: All