Phase I study of intratumoral injection of HF10, naturally occurring mutant of herpes simplex virus type 1

Phase I study of intratumoral injection of HF10, naturally occurring mutant of herpes simplex virus type 1 - Intratumoral injection of naturally occurring mutant of HSV-1

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007263

Enrollment

Registered

2012-02-10

Start date

2012-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-CNS malignant solid tumor

Interventions

HF10

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cytologically and/or histologically confirmed Non-CNS malignant solid tumor. 2) Refractory to standard therapies. 3) Life expectancy: >= 3 months from the date of consent. 4) Lesion to be treated: Measurable, easily accessible, and adequate for intratumoral injection. 5) Sero-positive to HSV-1. 6) Age: >= 20 years old. 7) Performance status (PS, ECOG scale): 0-2. 8) Adequate organ functions, measured as follows: White blood cells: >= 2,000/mm3 Lymphocyte cell: >= 800/mm3 Hemoglobin: >= 8.0g/dl Platelet: >= 50,000/mm3 Total birilbin: <= 1.5xULN AST (GOT): <= 3.0xULN ALT (GPT): <= 3.0xULN Serum creatinine: <= 1.5xULN PT INR: <= 1.5xULN 9) >= 4 weeks from prior therapy at start of HF10 injection. 10) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Past history of severe hypersensitivity. 2) Positive for HBs antigen, HCV antibody or HIV antibody. 3) Experience of autoimmune disease requiring treatment during 6 months prior to consent. 4) Active multiple primary malignancy. 5) With lesions, such as visceral metastases or bone metastases, which need emergent therapies. 6) Use of anti-HSV drugs. 7) Use of steroids or immune-suppressive drugs. 8) Patients with severe complications. 9) Presence of central nervous system metastasis. 10) Lesion to be treated: high risk of bleeding. 11) Lesion to be treated: high risk of penetration or perforation. 12) Use of anti-platelet drugs or difficult to cessation of them. 13) Use of anticoagulant which is unsafe for intratumoral injection. 14) Pregnant or breastfeeding. 15) Patients who deny contraception during this study. 16) Any other cases that the attending doctor judges not appropriate to enroll to this study.

Design outcomes

Primary

Measure	Time frame
MTD, DLT and adverse effects.	—

Secondary

Measure	Time frame
Anti-tumor activity	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026