Eligible participants (ECOG 0-1) have advanced solid tumors (e.g., NSCLC, pancreatic adenocarcinoma, RCC) refractory to prior therapies, with specific requirements per cohort (e.g., 2L NSCLC: anti-PD- (L)1 progression; 3L RCC: prior VEGFR TKI + immunotherapy). Key exclusions: cardiac/pulmonary dysfunction (NYHA III-IV, pneumonitis), uncontrolled hepatitis, recent immunosuppressants/radiotherapy, or hypersensitivity to study drugs. Lab thresholds include ANC ≥1000/uL, creatinine clearance ≥30 mL/min, and LVEF >50%. HCC requires Child-Pugh ≤7.

An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

Pharmacokinetics of TAK-500 (single/multi-dose) include Cmax, Tmax, AUCt, AUCinf, t1/2, CL, and Vss, measured during Cycles 1-4. Biomarkers assess intratumoral immune cell changes (IHC/ISH) and ADA immunogenicity. Tumor response metrics (ORR/DCR/DOR/TTR in escalation/expansion) follow RECIST 1.1, while survival endpoints (PFS/OS) track progression/death over ~50 months.