What side effects are associated with this type of intervention?

Common treatments for solid tumors include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy often causes side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation therapy can lead to skin irritation, fatigue, and localized side effects depending on the treatment area. Targeted therapies, which include drugs that specifically target cancer cells, can cause side effects like diarrhea, liver problems, and skin issues. For treatments similar to SGN1, which involve using therapeutic bacteria to deliver enzymes like L-Methioninase, potential side effects may include local inflammation at the injection site, immune reactions, and off-target effects due to the bacterial components.

What prior FDA approvals exist?

FDA approvals for the treatment of solid tumors have included various approaches such as targeted therapies, immunotherapies, and chemotherapies. While specific approvals for bacterial-based therapies like SGN1 are not detailed, treatments that interfere with tumor metabolism or use novel delivery mechanisms are being explored. For instance, pembrolizumab, an immunotherapy, has been approved for various solid tumors, demonstrating the FDA's support for innovative cancer treatments. Other metabolic interference strategies, such as tyrosine kinase inhibitors, have also been approved for certain solid tumors, highlighting the ongoing efforts to target cancer through diverse mechanisms.

What other types of research exist?

Promising novel alternatives to SGN1 for solid tumor treatment in 2024 include: 1) CAR-T cell therapies targeting specific tumor antigens, 2) Oncolytic viruses engineered to selectively infect and kill cancer cells, 3) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which enhance the body's immune response against tumors, and 4) Small molecule inhibitors targeting specific metabolic pathways essential for tumor growth, such as IDH1/2 inhibitors. These therapies have shown significant potential in clinical trials and are at the forefront of cancer treatment innovation.

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Virus Therapy

SGN1 Injection 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 first dosing, and at 2, 4, 6, and 24 hours post end of first infusion.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests SGN1, a modified bacterium injected into tumors, in patients with advanced solid tumors that don't respond to other treatments. SGN1 works by starving the tumor of a vital nutrient, methionine. The study aims to find the safest and most effective dose while checking for any side effects.

Who is the study for?

Adults aged 18-75 with advanced solid tumors that haven't responded to standard treatments or for whom no standard treatment exists. They must have a life expectancy of at least 12 weeks, an ECOG score of 0-1, and be able to follow up post-treatment. Women of childbearing age must use contraception.

What is being tested?

SGN1 is being tested as a potential cancer therapy for its ability to starve tumors by depleting essential amino acids. It's administered directly into the tumor and this study aims to find the safest dose with the best response in various advanced cancers.

What are the potential side effects?

Specific side effects are not listed but generally may include local reactions at injection sites, potential immune responses due to bacterial components, and typical symptoms associated with oncolytic therapies such as fever or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 7 days prior to first dosing, 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 first dosing, 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 first dosing, 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 of SAEs

Incidence of adverse events (AEs)

+2 more

Secondary study objectives

Assessment of tumor colonization

Immunogenicity (anti-drug antibodies)

Incidence of dose limiting toxicity (DLTs)

+6 more

Other study objectives

Expression changes of tumor immune microenvironment related indicators in tumor tissue

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

SGN1 will be injected into the target lesion intratumorally. According to the dose levels, the administered dose will be 0.5×108 CFU, 1×108 CFU, 2×108 CFU, 4×108 CFU, 6×108 CFU (optional). The patient will be administered once every week for 3 consecutive weeks followed by 1-week rest in 28-day treatment cycles. The duration of administration is until isease complete response/inability to continue intratumoral administration or disease progression, or intolerable toxicity or death or voluntary withdrawal or end of study, whichever came first. The standard 3+3 dose escalation algorithm will be applied to explore dose limiting toxicity (DLTs) in at least 4 sequential cohorts with 3- 6 patients and identify the maximally tolerated dose (MTD). When the cohort is completed in Part 1, the Part 2 study could be started according to the SMC evaluation. Enrollment of 2-4 dose level expansions will be opened to determine the safety and efficacy of SGN1 in specific tumor types

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The mechanism of action for SGN1 involves using a tumor-targeting bacterium to deliver L-Methioninase, an enzyme that depletes the tumor of essential amino acids like methionine, crucial for tumor growth. This method targets the metabolic vulnerabilities of cancer cells. Other common treatments for solid tumors include chemotherapy, which targets rapidly dividing cells; radiation therapy, which damages cancer cell DNA; and immunotherapy, which boosts the immune system's response against cancer cells. These treatments are vital for solid tumor patients as they provide multiple strategies to combat cancer, potentially improving outcomes and survival rates.