Study of SGN1 in Patients With Advanced Solid Tumor

NCT05038150 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SGN-P01-001
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of AEs (adverse events).

  An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. Events meeting the definition of an AE include: * Any abnormal laboratory test results (hematology, serum chemistry, or urinalysis) or other safety assessments (e.g., ECGs, vital signs measurements), including those that worsen from baseline, and was felt to be clinically significant in the medical and scientific judgment of the Investigator. * Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. * New conditions detected or diagnosed after study treatment administration even though it may have been present prior to the start of the study. * Signs, symptoms, or the clinical sequelae of a suspected interaction.

  From receiving study drug and throughout the study, until 28 days after the last dosing.

• Incidence of SAEs.

  An AE or suspected adverse reaction is considered "serious" if it results in any of the following outcomes: * Death * Life-threatening * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect * Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

  From receiving study drug and throughout the study, until 28 days after the last dosing.

• Objective response rate (ORR)

  The efficacy endpoints include ORR, DCR and PFS. The ORR is defined as the proportion of patients who achieve PR or better according to the RECIST v1.1 and Choi, mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.

  From signing the informed consent form until 28 days after the last dose.

• Disease control rate (DCR)

  The efficacy endpoints include ORR, DCR and PFS. The DCR is defined as the proportion of patients who achieve SD or better according to the RECIST v1.1 and Choi , mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.

  From signing the informed consent form until 28 days after the last dose.

• Progress Free Survival (PFS)

  The efficacy endpoints include ORR, DCR and PFS. PFS is defined as the time interval from date of first dose of SGN1 to the date of documented disease progression (iRECIST is used when the subject is suspected to have pseudo disease progression) or death due to any cause, whichever occurs first.

  From signing the informed consent form until 28 days after the last dose.

Secondary Outcomes (10)

• Incidence with any dose limiting toxicity (DLT),to determine the MTD.

  Up to 28 days post first dose.

• Incidence with adverse events and preliminary efficacy data to determine the OBD.

  From receiving study drug and throughout the study, until 28 days after the last dosing.

• PK analysis of SGN1 level in blood.

  For the first four infusions in Part 1 and Part 3

• Bacterial shedding of SGN1 level in blood.

  Before the first administration up to 28 days after the last dosing.

• Bacterial shedding of SGN1 level in urine.

  Before the first administration up to 28 days after the last dosing.

Other Outcomes (1)

• Tumor biomarkers upon cancer types

  From baseline until 28 days after the last dose.

Study Arms (1)

Cohort

EXPERIMENTAL

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 .

Drug: SGN1

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.

Also known as: SalMet-Vec

Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years inclusive of end value, regardless of gender.
• Part 1: Patients with advanced stage (unresectable or metastatic) cancer including but not limited to small cell lung cancer, non-small cell lung cancer (adeno- and squamous), Hodgkin's lymphoma or non-Hodgkin's lymphoma, sarcoma, cervical carcinoma, melanoma, head and neck cancer, breast cancer, ovarian cancer, pseudomyxoma peritoneum (Pseudomyxoma peritonei, PMP) and hepatocellular carcinoma characterized by failure of standard treatment (disease progression or intolerance, such as chemotherapy, targeted therapy, and other immunotherapies) or patients who have no standard treatment or patients who are intolerant to the standard treatment.
• Part 3: The specific tumor-type expansion study may enroll the following patients: Patients with hepatocellular carcinoma, small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), pancreatic cancer, prostate cancer, bladder cancer, nasopharyngeal carcinoma, sarcoma, melanoma or other tumor type with potential efficacy signal observed in Part 1\&2, who have failed to standard therapy or who are intolerant to the standard treatment. There will be 2-4 cohorts of dose expansion in specified tumor types.
• Note: For all tumor species included, standard treatment will refer to current CSCO/NCCN guidelines.
• Standard treatment failure refers to patients who have disease progression after CSCO/NCCN guidelines recommended existing standard care, or relapse/metastasis after standard care.
• Nonstandard treatment refers to patients who have received the treatment recommended by the guidelines and currently have no other effective treatment options.
• Patients finished anti-tumor therapy including chemotherapy, immunotherapy, biological agents, hormone therapy, radiotherapy (except local radiotherapy for pain relief) ≥ 4 weeks prior to the first dose of study drug.
• At least 1 measurable lesion according to RECIST 1.1 (for solid tumors).
• Patients have recovered from any toxic reaction to previous medications (≤Grade 1 based on NCI-CTCAE v 5.0, except a. Hair loss; b. Pigmentation; c. The long-term toxicity caused by radiotherapy and cannot be recovered by the investigator's judgment; d. Platinum induced neurotoxicity of grade 2 and below; e. Hemoglobin at 90 \~ 100 g / L (including boundary value)) or stable status assessed by the investigator.
• Eastern Co-Operative Oncology Group (ECOG) performance status 0 \~ 1 and a life expectancy of at least 3 months.
• Laboratory tests must meet the following requirements and have not received any blood cell growth factor 14 days before the test (Patients with laboratory values outside of the specified ranges will be permitted to be retested in order to meet the criteria):
• absolute count of neutrophils (ANC) ≥1.5×109 /L, platelet ≥75×109 /L; Hemoglobin ≥90 g/L;
• serum albumin ≥30g /L; Bilirubin ≤1.5 × Upper Limit of Normal (ULN), ALT and AST ≤2.5 × ULN;
• In patients with liver metastasis,ALT and AST≤5 × ULN;
• Creatinine clearance ≥50 mL/min (standard Cockcroft -Gault formula) or Cr ≤1.5 ×ULN: urinary protein≤ 2+ or urinary protein quantitative \<1.0 g/L;

You may not qualify if:

• Patients will be excluded from participation for any of the following criteria:
• Received systemic or absorbable dosage of steroid hormone (prednisone or equivalent) of \> 10 mg/day in the 14 days prior to enrollment;
• Prednisone \> 10 mg/day
• Dexamethasone \> 1.5 mg/day.
• Allergic or intolerant to salmonella sensitive antibiotics, or combined with infectious diseases and currently using antibiotics.
• Present assessable tumors in hollow organs (Stomach, esophagus, intestine, urinary tract etc.).
• Present with symptomatic central nervous system metastasis or brain abscess at screening.
• Present with diverticulitis or conditions at screening that might promote the unintentional growth of anaerobic bacteria in non target lesions.
• Existing cardiac clinical symptoms or diseases that cannot be well controlled, such as:
• NYHA grade 2 or above heart failure;
• Unstable angina pectoris;
• Myocardial infarction occurred within 1 year;
• Patients with supraventricular or ventricular arrhythmias that have clinical significance and need treatment or intervention;
• Uncontrolled hypertension (systolic blood pressure) ≥160 mmHg and (diastolic blood pressure) ≥100 mmHg after drug treatment;
• Patients with valvular heart disease or mitral valve prolapse, aortic valve disease or other source of turbulent cardiac blood flow.

Sponsors & Collaborators

• Guangzhou Sinogen Pharmaceutical Co., Ltd: lead

Study Sites (8)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

SUSPENDED

Health Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

SUSPENDED

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Michigan, 48201, United States

WITHDRAWN

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267, United States

SUSPENDED

Guangdong Clifford Hospital

Guangzhou, Guangdong, 511495, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Yifan Xu

CONTACT

+86 18516560587; yifan.xu2@pharmaron.com

Weiyun Jia

CONTACT

(+86) 13810385484; Weiyun.Jia@pharmaron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will employ a standard 3 + 3 escalating dose design to explore dose limiting toxicities (DLTs). Currently plans to evaluate 5 cohorts with 3- 6 patients to determine the Maximum Tolerated Dose (MTD). Patients who had no dose-limiting toxicities observed in Part 1 proceeded to Part 2. Alternatively, if a DLT occurs in only 1/3 patients at any dose, then 3 more patients should be enrolled at this dose level. If this is the highest dose and there have been no DLTs-then 3 more patients must be evaluated at the same dose level to confirm the MTD. The MTD is defined as the highest dose at which no more than one (1) DLT is observed among 6 patients. 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.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 8, 2021
• Study Start: January 16, 2023
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CN (4)