Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor
Status:
Not yet recruiting
Trial end date:
2025-04-04
Target enrollment:
Participant gender:
Summary
Objectives：To characterize safety, tolerability, MTD and RP2D, PK, biological distribution,
immunogenicity, and preliminary efficacy of intratumoral injection of SGN1 in patients with
advanced solid tumors.
Study Rationale:The mechanism of action for SGN1 is based on the fact that most tumors are
methionine dependent. SGN1 is designed to be used as a tumor therapeutic bacterium that can
preferentially replicate and accumulate in tumors and starve them of essential amino acids by
delivering the oncolytic enzyme L-Methioninase.
Patient Population:Patients with advanced head and neck squamous cell carcinoma(HNSCC), who
have disease progression after receiving at least one standard systemic treatment in the
past, or who are intolerant to or unable to receive the curative or life-prolonging standard
of care available therapies. Patients should have target lesions suitable for intratumoral
injection of SGN1.