Study of SGN1 in Patients with Advanced Solid Tumors

Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05038150

Provider View

This clinical trial is testing a new treatment called SGN1 for patients with advanced solid tumors that have not responded to standard treatments. The study aims to determine the safety and effectiveness of SGN1, which is designed to target and starve tumors by using a special enzyme.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and initial effectiveness of a new treatment called SGN1 in patients with advanced solid tumors that have not responded to standard therapies. SGN1 works by targeting tumors that rely on a nutrient called methionine. It uses a modified bacterium to deliver an enzyme that depletes methionine, potentially starving the tumor cells. The study will be conducted in multiple phases to determine the best dose and assess the treatment's impact on different types of tumors.

Description

SGN1 is a new treatment that uses a modified bacterium to target and starve tumors by depleting a nutrient called methionine, which many tumors need to grow. This study will test SGN1 in patients with advanced solid tumors that have not responded to other treatments. The study is divided into three parts:

  • Part 1 & 2: These are the initial phases where the safety of SGN1 is tested, and the dose is gradually increased to find the best level. Patients will continue treatment unless they experience severe side effects, their cancer progresses, or they choose to stop.

  • Part 3: This phase expands the study to include more patients with specific types of tumors to further evaluate the treatment's effectiveness.

Participants will be closely monitored for side effects and the treatment's impact on their cancer. If the treatment is not effective or causes severe side effects, patients may receive other supportive care.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 75 with advanced or metastatic solid tumors that have not responded to standard treatments.
  • Must have completed any previous cancer treatments at least 4 weeks before starting the study.
  • Must have at least one measurable tumor.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Women must not be pregnant and must agree to use effective contraception during and for 6 months after treatment.
  • Men must agree to use effective contraception during and for 6 months after treatment.
  • Must be able to follow up after treatment and understand the study, agreeing to sign informed consent.

Exclusion Criteria

  • Recent use of high-dose steroids or allergies to certain antibiotics.
  • Tumors in hollow organs like the stomach or intestines.
  • Active brain metastases or certain infections.
  • Uncontrolled heart conditions or high blood pressure.
  • Recent cancer treatments or participation in other clinical trials.
  • Recent vaccinations with live vaccines.
  • Other medical conditions that may interfere with the study or pose a risk to the patient.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.