CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 21 target
Drug / intervention
Lysogenic HSV virus. +2 morebiological
Likely dose
Lysogenic HSV virus. 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06741982
NCT06741982Phase 1RecruitingOn TrackUpdated 18mo ago
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A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

West China Hospital·interventional·Posted Dec 19, 2024·Updated Dec 19, 2024

In Brief

A Phase 1 clinical trial evaluating Lysogenic HSV virus., Tislelizumab, and 1 other intervention for HNSCC and 4 related conditions. Currently recruiting, targeting 21 participants across 1 site.

Detailed Summary

Evaluation of the safety and tolerability of immune-targeted therapy combined with neoadjuvant therapy with lysogenic HSV virus for patients with surgically resectable squamous carcinoma of the head and neck.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHNSCC, Lysogenic HSV Virus, Neoadjuvant Therapy, Immunotherapy, Targeted Therapy
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
202520262027
First PostedDec 19, 2024
Enrollment StartDec 15, 2024
Primary CompletionDec 15, 2026
TodayJul 1, 2026
Enrollment to primary: 2 yearsPosted 1.5 years agoPrimary completion in 5 months

Interventions

Lysogenic HSV virus.biological

Lysosomal HSV virus injection (divided into a dose-escalation phase and a dose-expansion phase; in the dose-escalation phase, Group 1 took 106 pfu/mL and Group 2 took 108 pfu/mL, and in the dose-expansion phase the dose of lysosomal HSV virus with the highest MPR of the escalation phase was taken.) .. The dose of intralymph node injection of lysosomal HSV virus in patients was determined according to the size of metastatic lymph nodes, (diameter less than or equal to 1.5 cm, maximum 1 mL; diameter 1.5-2.5 cm, maximum 2 mL; diameter greater than 2.5 cm, maximum 4 mL). Two injections were given per patient, with each dose separated by 2 weeks.

Tislelizumabdrug

200mg IV Q3W

Afatinibdrug

30mg PO QD