Intensity Therapeutics published the manuscript for its Phase 1/2 IT‑01 study in eBioMedicine on October 29, 2025. The open‑access article, titled “Safety and Efficacy of Intratumourally Administered INT230‑6 in Adult Patients with Advanced Solid Tumours: Results from an Open‑Label Phase 1/2 Dose‑Escalation Study,” details the first‑in‑human evaluation of INT230‑6, a combination of cisplatin, vinblastine sulfate, and a SHAO enhancer.
The study was an open‑label, single‑arm, dose‑escalation trial that enrolled patients with more than 20 metastatic solid tumor types across six clinical sites and the University of Southern California. Participants were heavily pre‑treated and had progressed after multiple prior lines of therapy. INT230‑6 was delivered intratumorally, with the SHAO enhancer designed to improve drug dispersion and immune activation.
Key efficacy results included a disease‑control rate of 75 % (48 of 64 patients) overall and 83.3 % (40 of 48 patients) in the subset of patients whose total tumor burden received >40 % of the dose. Median overall survival was 11.9 months overall, 18.7 months for the >40 % TTB group, and 3.1 months for the <40 % TTB group. In a metastatic sarcoma subset, median overall survival reached 21.3 months. At least 20 % of patients with high tumor burden exhibited systemic immune activation and abscopal effects, indicating shrinkage of non‑injected tumors.
Safety data were favorable. Most adverse events were low‑grade and transient; no dose‑limiting toxicities or grade 4/5 treatment‑related events were reported. Grade 3 adverse events occurred in 10.9 % of patients, and the overall safety profile supports continued clinical development.
The publication is a milestone that supports Intensity Therapeutics’ plan to advance INT230‑6 toward regulatory submissions. The company has launched a Phase 3 sarcoma study (INVINCIBLE‑3), a Phase 2 presurgical triple‑negative breast cancer study in partnership with the Swiss Cancer Institute, and a collaboration with Merck to evaluate INT230‑6 in combination with KEYTRUDA. A webinar to discuss the findings is scheduled for October 31, 2025.
The data reinforce the company’s intratumoral therapy platform and provide a foundation for future randomized studies, positioning INT230‑6 as a potential new treatment option for patients with advanced solid tumors.
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