| Phase | Design | Population | Primary Endpoint | Status | |-------|--------|------------|------------------|--------| | | 3 + 3 design, oral daily dosing | Advanced solid tumors refractory to standard therapy (incl. melanoma, NSCLC, colorectal) | Safety, MTD, PK/PD, Preliminary efficacy (RECIST v1.1) | IND filed (April 2024). Expected start Q3 2025. | | Phase Ib (combo) | Fixed dose of MIAA‑376 + anti‑PD‑1 (pembrolizumab) | Metastatic melanoma with prior anti‑PD‑1 failure | ORR, DOR, Immune biomarkers | Protocol development underway. | | Phase II (biomarker‑enriched) | Randomized 1:1 MIAA‑376 + PD‑1 vs. PD‑1 alone | BRAF‑wildtype, high MIA‑A expression (RNA‑seq cut‑off) | PFS, OS, Biomarker correlation (MIA‑A serum levels) | Planned for 2027 pending Phase I read‑out. |
I should conclude by emphasizing the need for more information if the user has a specific MIAA-376 in mind, to provide a more accurate and detailed feature. MIAA-376
Based on this draft review, I recommend that the study be considered for publication with revisions addressing the outlined weaknesses and limitations. The study's findings and contributions to the field make it a worthwhile addition to the existing literature, and with revisions, it has the potential to make a more significant impact. | Phase | Design | Population | Primary