Sone-214 Jun 2026

Sone-214 is an emerging clinical candidate, with several clinical trials currently underway to evaluate its efficacy and safety in patients with advanced cancer. These trials, including an ongoing Phase 1 study and a Phase 2 trial in NSCLC, are designed to assess the safety, tolerability, and anti-tumor activity of Sone-214 when administered as a single agent or in combination with other anticancer agents.

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The official listing is on the FANZA (formerly DMM) website, which is the primary distributor for JAV in Japan. sone-214

| Phase | Status | Key Milestones | |-------|--------|----------------| | | Completed 2022 (GLP tox, CMC) | IND submission to FDA (March 2023) | | Phase I (first‑in‑human, healthy volunteers) | Completed (Oct 2023) | • Single‑ascending dose (SAD) up to 150 mg – tolerable. • PK: Cmax at 2 h; half‑life ≈ 7 h; linear exposure 10‑150 mg. • PD: IFN‑β ↑ 3‑5‑fold at 50 mg; IL‑6 unchanged. • No serious adverse events (SAEs). | | Phase I/IIa (oncology – solid tumors) | Ongoing (as of Apr 2024) | • Open‑label, dose‑escalation (25‑100 mg PO daily) in patients with advanced melanoma, NSCLC, and pancreatic cancer. • Primary endpoint: safety/tolerability; secondary: ORR, PFS, immune‑gene signatures. | | Phase IIb (combination with anti‑PD‑1) | Planned for H2 2025 | • Multi‑center, randomized (SO‑214 + pembrolizumab vs. pembrolizumab alone) in refractory melanoma and head‑and‑neck SCC. | | Regulatory | IND active; fast‑track designation granted (FDA, Dec 2023) for “immunogenic tumor conversion”. | | Sone-214 is an emerging clinical candidate, with several

Here are the detailed features of this specific title: | Phase | Status | Key Milestones |