A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors

Primary: Dose Escalation Phase: Change in vital signs measurements, clinical laboratory assessment, 12-lead electrocardiograms (ECGs), physical examinations (including Eastern Cooperative Oncology Group [ECOG] Performance Status [PS]), and urinalyses, Dose Escalation Phase: Establishing the Maximum Tolerated Dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 administered as monotherapy, Dose Escalation Phase: Incidence and severity of Treatment-emergent adverse event (TEAEs) and laboratory abnormalities, Dose Escalation Phase: Incidence of treatment discontinuations and treatment modifications due to adverse events (AEs) and laboratory abnormalities, Dose Escalation Phase: Incidence of treatment-emergent serious adverse events (TESAEs), Dose Expansion Phase: Tumor response: Best Overall Response (BOR), Dose Expansion Phase: Tumor response: Disease Control Rate (DCR), Dose Expansion Phase: Tumor response: Overall Response Rate (ORR)

Secondary: Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (maximum plasma concentration [Cmax]), Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (time to maximum concentration [Tmax]), Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent clearance [CL/F], Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent first-order terminal elimination rate constant [λz], Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent volume of distribution [Vz/F], Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to infinity [AUC∞], Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to the time of last quantifiable plasma concentration [AUC0 t], Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to time τ [AUCτ]