演題抄録

デジタルポスター

開催概要
開催回
第55回・2017年・横浜
 

Phase I Trial of HF10, a Replication-competent HSV-1 oncolytic Immunotherapy, in Patients with Refractory Superficial Cancers

演題番号 : P123-7

[筆頭演者]
並川 健二郎:1 
[共同演者]
高橋 聡:1、堤田 新:1、田中 舞紀:2、山崎 直也:1

1:国立研究開発法人国立がん研究センター中央病院・皮膚腫瘍科、2:タカラバイオ株式会社

 

Background
HF10, an attenuated, replication-competent mutant strain of Herpes Simplex Virus type 1 (HSV-1), is a promising new oncolytic viral immunotherapy. HF10 (intratumoral injection) showed activity in injected lesions and uninjected lesions in the preclinical and the clinical. To assess the safety and tolerability of HF10, we conducted a Phase I trial in the Japanese patients with refractory solid tumors with cutaneous and/or superficial lesions.
Methods
The study was an open label, non-randomized, dose escalation study evaluating 2 dose levels of HF10 (1 × 106, 1 × 107 TCID50/dose). Dose escalation proceeded according to a 3+3 design. HF10 injected into single tumor up to 4 injections (≧ 2 weeks apart). Adverse events (AEs) were evaluated according to NCI CTCAE v4.0. Evaluation criteria at sequential timepoints included overall and injected tumor response per mWHO criteria; safety; viral detection by qPCR.
Results and Conclusion
Six patients (pts) with melanoma or other skin cancers were enrolled and treated. Of 6 safety evaluable pts, no DLTs were reported. HF10-related AEs occurred in 3 pts (Grade(Gr) 1 Malaise in 2pts, Gr 1 Headache and Gr 1 Abdominal pain in 1 pt). These AEs were easily managed, and no HF10-related serious AEs were reported. HF10 virus shedding in biological fluids was not detected in the majority of patients treated. In the minority of patients who showed positive, detection was transient and restricted to saliva. The results of the virus detection analysis indicate that HF10 poses minimal infectious risk to treated patients or persons with whom they have contact. Of 6 efficacy evaluable pts, 4 pts showed NC (No change) and 2 pts showed PD. In summary, multiple intratumoral injections of HF10 in superficial tumors were well-tolerated and appeared to be safe. Comparing the results from the Phase I in the US, it was considered that there was no significant difference in the safety profile between the US and Japanese trials.

キーワード

臓器別:皮膚

手法別:腫瘍免疫

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