SGN1 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Guangzhou Sinogen Pharmaceutical Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 7 days prior to the first dose, and at 2, 4, 6, and 24 hours post end of first infusion.

Awards & highlights

No Placebo-Only Group

Summary

This trialtests a new therapy for cancer patients with tumors that don't respond to standard treatments. It uses a modified bacteria to starve the tumor of essential amino acids.

Who is the study for?

This trial is for adults aged 18-75 with advanced solid tumors that haven't responded to standard treatments or have no other treatment options. Participants must have at least one measurable tumor, be in relatively good health (ECOG status 0-1), and have a life expectancy of over three months. Women must not be pregnant or breastfeeding and use contraception if of childbearing potential; men also need to agree to use contraception.

What is being tested?

SGN1, a genetically modified Salmonella bacterium designed to target and kill cancer cells by starving them of methionine, an amino acid essential for tumor growth. This study will first determine the safe dosage levels (safety/tolerability) followed by an expansion phase to assess preliminary effectiveness against various refractory solid tumors.

What are the potential side effects?

Potential side effects may include typical reactions associated with bacterial infections such as fever, chills, fatigue along with site-specific inflammation due to bacteria accumulation in the tumors. As SGN1 is a new therapy, there may be unforeseen side effects related to its unique mechanism of action.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 7 days prior to the first dose, and at 2, 4, 6, and 24 hours post end of first infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 7 days prior to the first dose, and at 2, 4, 6, and 24 hours post end of first infusion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days prior to the first dose, and at 2, 4, 6, and 24 hours post end of first infusion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease control rate (DCR)

Incidence and severity of AEs (adverse events).

Incidence of SAEs.

+2 more

Secondary study objectives

Anti-Drug antibody (ADA) of SGN1.

Assessment of tumor colonization.

Bacterial shedding of SGN1 level in blood.

+7 more

Other study objectives

Tumor biomarkers upon cancer types

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CohortExperimental Treatment1 Intervention

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 .

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