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Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor

NCT05103345 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-05

No results posted yet for this study

Summary

Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes.

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 presenting with histologically confirmed advanced and/or metastatic solid tumors that are refractory to standard therapy and for which no other conventional therapy exists.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

SGN1

SGN1,will be administered intratumorally,which dosage is 0.9-2.0×109 cfu /vial.

Sponsors & Collaborators

  • Pharmaron

    collaborator INDUSTRY

  • Guangzhou Sinogen Pharmaceutical Co., Ltd

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • China
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103345 on ClinicalTrials.gov