Study of SGN1 in Patients With Advanced Solid Tumor

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Guangzhou Sinogen Pharmaceutical Co., Ltd
Study ID
NCT05038150
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SGN1 — DRUG
    The study drug, SGN1, will be administered as an IV infusion through a dedicated line catheter over 2 hours, which unit dose strength is 0.9-2.0×109 cfu /vial.

Study Details

Objectives:To assess the safety and tolerability followed by a dose expansion study to characterize safety, and preliminary efficacy of SGN1 in participants with refractory 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:The treatment populations shall be 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.

Key Dates

Start date
Jan 16, 2023
Status verified
Apr 2026
Primary completion
Jan 18, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort
    In part 1\&2, cohorts of 3 patients will be enrolled. The first patient of each cohort in Part 1 will be admitted to an infusion unit and treated with an IV infusion of SGN1 over 2 hours. Patients in Part 1 will enter Part 2 for extension treatment after completing the 28-day DLT observation period. Up to 5 cohorts will be evaluated. Part 3 is an open-label, dose expansion phase.There will be at least 2 tumor types selected, expand between second to four dose level in each tumor type .

Primary Outcome Measure

Incidence and severity of AEs (adverse events). [ Time Frame: From receiving study drug and throughout the study, until 28 days after the last dosing. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Health Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterDetroitMichigan48201-
University of Cincinnati Cancer CenterCincinnatiOhio45267-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZHealth Chao Family Comprehensive Cancer Center· Orange, CABarbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center· Detroit, MIUniversity of Cincinnati Cancer Center· Cincinnati, OH

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