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Advanced Solid TumorPhase 1/2NCT05103345

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor

A Phase 1/2 study testing SGN1 in people with Advanced Solid Tumor, run by Guangzhou Sinogen Pharmaceutical Co., Ltd at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SGN1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
4 sitesin 2 countries
Study dates
19 Apr 2023to 30 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be enrolled in the study, patients who have laboratory values outside of the specified ranges will be permitted to be retested. Patients who meet the following criteria at the screening visit will be eligible for participation in the study:
  • Male or female aged 18~75 years((including 18 and 75 years)) at the time of informed consent;
  • Part 1: Patients with advanced stage (unresectable or metastatic) solid tumors 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 intolerable to standard treatment; Note: For all tumor species included, standard treatment will refer to current Chinese Society of Clinical Oncology (CSCO)/National Comprehensive Cancer Network (NCCN) guidelines.
  • Standard treatment failure refers to patients who have disease progression after the existing standard of care recommended by CSCO/NCCN guidelines, or relapse/metastasis after standard of care.
  • Non-standard treatment refers to patients who have received the treatment recommended by the guidelines and currently have no other effective treatment options.
  • Part 2: the specific tumor-type expansion study may enroll the following patients: Patients with advanced HNSCC, Sarcoma, HCC, cervical cancer, melanoma, or other tumor type with potential efficacy signal observed in Part 1, who have failed to standard therapy or who are intolerant to the standard treatment.
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  • Patients must have the main lesion suitable for local injection of SGN1. The tumors must be in situ or metastatic solid tumors that are subcutaneous, palpable, or can be injected directly using methods including but not limited to color doppler ultrasound guidance, which is the preferred method. If the Investigator(s) judge(s) it necessary, the intratumoral injection can also be performed under CT guidance by an interventional radiologist or specialist with adequate qualifications and trainings, provided that these tumors do not invade the walls of blood vessels or hollow organs confirmed by previous imaging studies and Investigator assessment (no risk of major bleeding or hollow organ perforation).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Life expectancy ≥ 12 weeks.
  • Patients have recovered from any toxic reaction to previous medications (≤Grade 1 based on NCI-CTCAE v 5.0, except
  • Hair loss;
  • Pigmentation;
  • The long-term toxicity caused by radiotherapy and cannot be recovered by the Investigator's judgment;
  • Platinum induced neurotoxicity of grade 2 and below;
  • Hemoglobin at 90 ~ 100 g/L (including boundary value) or stable status assessed by the Investigator.
  • Patients with adrenal and thyroid dysfunction who maintain a stable state after drug treatment as judged by the Investigator may be included in this study; Patients with toxic reactions of single indicator grade 2 or above that with no clinical significance or clinical treatment measures, which will be determined by the investigator if not affect the study, can also be included.
  • At least one measurable injected lesion as determined by RECIST 1.1(for solid tumors).
  • Laboratory tests must meet the following requirements and have not received any blood cell growth factor 14 days before the test and no blood transfusions within 14 days prior to screening (patients with laboratory values outside of the specified ranges will be permitted to be retested during the screening period 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 ≥ 30 g/L; Bilirubin ≤1.5 × 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;
  • International standardized ratio of coagulation function (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (if the patient is taking concomitant anticoagulant medication, whether the coagulation function is qualified will be determined by the Investigator).
  • If female, be either postmenopausal for at least 1 year with documented follicle stimulating hormone (FSH) >30 IU/L, or surgically sterile for at least 3 months, or if a woman of childbearing potential, must be non-pregnant confirmed by blood and urine pregnancy tests, and non-lactating.
  • Female patients of childbearing potential must agree to use acceptable method(s) of contraception from consent through at least 6 months after the last dose of drug intratumoral injection.
  • Male patients of reproductive capacity must agree to use effective contraception from start of mobilization through at least 6 months after the last dose of drug intratumoral injection.
  • Patients must be able to follow up after the treatment.
  • Patients must understand and voluntarily sign the informed consent form.

Who cannot join

  • Patients will be excluded from participation of the study for any of the following criteria:
  • Prior treatment with oncolytic bacteria viral or anti-tumor bacteria therapy.
  • Patients with extremely large tumor (the longest diameter of a single tumor does not exceed 8 cm in principle); patients with multiple lesions cannot receive intratumoral injection, it mainly refers to patients with extensive metastasis who are not suitable for local treatment;
  • Patients who are allergic or intolerant to salmonella sensitive antibiotics, and have infectious diseases and are currently using antibiotics.
  • Present assessable tumors in hollow organs (stomach, esophagus, intestine, urinary tract etc.).
  • Patients who are known to be allergic to the investigational drug or any of its excipients; or rescue medications; or have a severe allergic reaction to other monoclonal antibodies.
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  • Patients who have received the following treatments or drugs before the first treatment with the investigational drug:
  • Major surgery performed within 28 days before the first treatment with the investigational drug (biopsy is allowed for diagnostic purposes);
  • Immunosuppressive drugs have been administered within 14 days before the first treatment with the investigational drug (Prednisone >10 mg/day, or equivalent doses of corticosteroids), excluding corticosteroid nasal sprays and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., prednisone not exceeding 10 mg/d or equivalent physiological doses of other corticosteroids);
  • Inoculation of (attenuated) live virus vaccine: within 28 days before the first dosing of study drug, or during the study period or 60 days after the last dose of study drug; Except for administration of inactivated vaccines and RNA vaccines (e.g., inactivated influenza vaccines and COVID-19 RNA vaccines);
  • Any anti-tumor therapies (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 28 days before the first dosing of the investigational drug (if nitrosourea or mitomycin chemotherapy the interval between end of chemotherapy and first dose of study treatment must be no less than 6 weeks).
  • Patients with known uncontrollable or symptomatic active CNS metastases, manifested by clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth. Patients with a history of metastases to the central nervous system or spinal cord compression can be included in the study if they have clearly received treatment and have shown stable clinical manifestations after the discontinuation of anticonvulsants and steroids for 4 weeks before the first dose of the investigational drug.
  • Present with diverticulitis that may cause anaerobic bacteria to multiply or conditions at screening that might promote the unintentional growth of anaerobic bacteria in nontarget lesions.
  • Symptomatic, advanced patients whose tumors have spread to the internal organs and are at risk of life-threatening complications in the short term (including patients with uncontrollable large amounts of effusion (thoracic cavity, pericardial cavity, or abdominal cavity);
  • Patients with any active autoimmune diseases or a history of any autoimmune disease with predictable recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [only patients whose condition can be controlled by hormone replacement therapy can be included]; Patients with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, hair loss, Type I diabetes mellitus, or those with childhood asthma which has been completely relieved and requires no interventions in adulthood, can be included. Those with asthma who need bronchodilators for medical intervention cannot be included);
  • Patients with other active malignant tumor(s) within 2 years before entering the study. Patients with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent may be included at the judgment of the Investigator.
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as: hepatitis B virus surface antigen [HbsAg] testing positive, HBV-DNA ≥ 500 IU/mL and abnormal liver function; hepatitis C, defined as: hepatitis C antibody [HCV-Ab] testing positive, higher HCV-RNA than the lower limit of detection of the analysis method and abnormal liver function) or hepatitis B and hepatitis C co-infection;
  • 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.
  • Patients with active or uncontrolled infection or fever > 38.5°C of unknown cause or before the first administration of the study drug;
  • Documented salmonella infection within 6 months.
  • Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  • Patients participating in other clinical studies or participating in other clinical studies within 4 weeks or 5 half-lives of other study drugs, whichever is longer, prior to enrollment and receiving experimental drug administration.
  • Known history of psychotropic drug abuse or recreational drug abuse;
  • In the judgment of the Investigator, there are other factors that may lead to termination: for example, adrenal cortex insufficiency, pituitary insufficiency after treatment, and other serious diseases (including mental diseases) need to be treated together, there are serious abnormalities in laboratory examination, family or social factors, which may affect the safety of the patients or test data and sample collection.
  • Patients with implants such as pacemakers, prosthetic cardiac valves, or vascular stents who require long-term anticoagulant therapy;
  • In the Investigator's judgment, patients who are not suitable for other reasons;
  • Abdominal standing position plain film or abdominal CT indicates the possibility of bowel obstruction within 6 months from screening, or the Investigator believes there is a risk of bowel obstruction.

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Edwin chen contact

(+86)13427504628

chenhd@sinogen.cc

Weiyun Jia contact

(+86) 13810385484

Weiyun.Jia@pharmaron.com

4 sites in 2 countries

China2 sites, 2 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Li Zheng, MD, +86 19180720591, lzheng2005618@163.com

    Recruiting

  • Guangdong Clifford Hospital

    Guangzhou, Guangdong, 511495

    Qichun Cai, +86 136 7050 9007, purecai@163.com

    Recruiting

Other trials in China

Taiwan2 sites, 2 recruiting

  • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

    New Taipei City, 23561

    Wei-Hong Cheng, +886-970-747-287, 13520@s.tmu.edu.tw

    Recruiting

  • China Medical University Hospital

    Taichung

    Ching-Yun Hsieh, +886-4-22052121 ext.5057, D7995@mail.cmuh.org.tw

    Yu-Ting Ho, '+886-4-22052121 ext.5057, blessyou1982@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase I/IIa, Open-label, Dose Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Modified Salmonella Typhimurium SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors

Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes.

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: 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.

Read the detailed description

Methionine starvation can powerfully modulate DNA methylation, cell cycle transition, polyamines and antioxidant synthesis of tumor cells, in contrast to normal ones. L-Methioninase is a pyridoxal phosphate dependent enzyme that catalyzes the γ-elimination reaction of L-methionine to methanethiol, α-ketobutyrate and ammonia . Absolute-dependency on exogenous supply of L-methionine, not homocysteine, for growth and proliferation of tumors is the pivotal biochemical criterion for various human cancers.

SGN1 is a genetically modified strain of Salmonella enterica, serotype typhimurium that expresses L-Methioninase. The attenuated live bacterium has been investigated in China for utility in treating advanced solid tumors. 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.

This study is a multi-center phase I/IIa clinical trial with 2 parts:

Part 1 is a phase I open-label, dose escalation study phase. The purpose of Part 1 is to characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors. Part 2 is as a part of a phase Ib/IIa study, which is a specific Tumor-type expansion study, the purpose of Part 2 is to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes at Safety Monitoring Committee (SMC) determined doses.

SGN1 will be administrated in 28-days cycles (once weekly for 3 weeks followed by 1-week rest). Intratumoral injection of SGN1 can be performed directly using methods including but not limited to color doppler ultrasound guidance, which is the preferred method. If the Investigator(s) judge(s) it necessary, the intratumoral injection can also be performed under CT guidance by an interventional radiologist or specialist with adequate qualifications and trainings.

Being tested
SGN1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGN1Drug

    Also called SalMet-Vec

    SGN1,will be administered intratumorally,which dosage is 0.9-2.0×109 cfu /vial.

Study groups in NCT05103345
Study groupRoleWhat they receive
CohortOtherSGN1 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
Receives: Drug: SGN1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    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.

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

  2. Incidence of SAEs

    An AE or suspected adverse reaction is considered "serious" if it results in any of the following outcomes:

    • Death
    • Life-threatening
    • In patient 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.

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

  3. 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. mRECIST is used to assess Hepatocellular carcinoma only, Choi criteria is used for all solid tumors, during the whole study, as the only exploratory tumor assessment method in the study, and LYRIC is used to assess Lymphoma as assessed by the investigator.

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

  4. 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, mRECIST is used to assess Hepatocellular carcinoma only, Choi criteria is used for all solid tumors, during the whole study, as the only exploratory tumor assessment method in the study, and LYRIC is used to assess Lymphoma as assessed by the investigator.

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

  5. Progression 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 patient is suspected to be pseudo disease progression) or death due to any cause, whichever occurs first.

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

Secondary outcomes (9)

  1. Incidence of dose limiting toxicity (DLTs)

    Any of the following judged to be associated with SGN1 may be considered a DLT:

    1. Any Grade 5 adverse event that is at least possibly related to investigational drug
    2. Non-hematological toxicities:
    3. Grade 4 non-hematological toxicities (excluding alopecia) lasting > 3 days despite optimal supportive care (OSC).
    4. Grade 3 non-hematologic toxicities lasting > 7 days despite OSC.
    5. Hematological toxicities:
    6. Grade 4 hematologic toxicities lasting > 7 days (except following b and c).
    7. Grade 3 or 4 febrile neutropenia (body temperature ≥38.5°C) lasting > 7 days.
    8. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia.

    Measured: Up to 28 days post first dose

  2. SGN1 level in blood for PK analysis

    In Part 1 and Part 2, blood sampling will be collected for pharmacokinetics (PK).

    The blood collection times for PK are within 30 minutes predose and 30 minutes postdose of intratumoral injection on C1D1(cycle1 day1), C1D8(cycle1 day8), C1D15(cycle1 day15), C2D1(cycle2 day1), C2D8(cycle2 day8), and C2D15(cycle2 day15), and at the following timepoints after the end of dose on C1D1 and C2D1: 5 minutes (± 1 minute), 10 minutes (± 1 minute), 1 hour (± 2 minutes), 1.5 hours (± 2 minutes), 2 hours (± 2 minutes), 4 hours (± 5 minutes), 6 hours (± 10 minutes), 8 hours (± 15 minutes), 24 hours ± 1 hour, 48 hours ± 1 hour, 72 hours ± 1 hour. If there are still symptoms of fever or infection after 72 hours, extend the PK collection time and expect to increase it every 24 hours(± 1 hour) until the infection symptoms disappear.

    Measured: Before and after SGN1 injection in the first two cycles in Part 1 and Part 2.

  3. Immunogenicity (anti-drug antibodies)

    Anti-drug antibody blood sample collection time points: each predose (within 2 days) in the first 2 cycles, before the first dose in Cycles 3 and 4 (within 2 days), and at the EOT/withdrawal visit.

    Measured: Before and after SGN1 injection in the first 4 cycles in Part 1 and Part 2.

  4. SGN1 level in blood for bacterial shedding.

    In Part 1 and Part 2,blood samples will be collected for Bacterial Shedding.

    Blood samples will be collected within 2 hours prior to the start of SGN1 intratumoral injection on C1D8 and C1D15, and within 24±3 hours after the end of each SGN1 intratumoral injection on C1D8 and C1D15.

    Blood bacterial samples within 30 minutes predose and 30 minutes postdose of intratumoral injection on C1D1, C1D8, C1D15, C2D1, C2D8, and C2D15 are measured in the PK analysis described above. The results from PK blood samples will contribute to the analysis as the bacterial shedding.

    In EOT/ET visit, blood samples for bacterial shedding will be collected.

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

  5. SGN1 level in urine for bacterial shedding.

    In Part 1 and Part 2, urine samples will be collected for Bacterial Shedding.

    For the first SGN1 administration (C1D1), urine sampling will be conducted within 2 hours before intratumoral injection, 3 hours ±1 hour, 6 hours ±1 hour, 24 hours ±3 hours, 48 hours ±3 hours and 72 hours ±3 hours after end of intratumoral injection.

    For the second and third administration(C1D8 and C1D15),urine samples for bacterial shedding will be collected within 2 hours prior to the start of SGN1 intratumoral injection, and within 24 ± 3 hours after the end of each SGN1 intratumoral injection.

    In EOT/ET visit, urine samples for bacterial shedding will be collected.

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

  6. SGN1 level in saliva for bacterial shedding.

    In Part 1 and Part 2, saliva samples will be collected for Bacterial Shedding.

    For the first SGN1 administration (C1D1), saliva sampling will be conducted within 2 hours before intratumoral injection, 3 hours ±1 hour, 6 hours ±1 hour, 24 hours ±3 hours, 48 hours ±3 hours and 72 hours ±3 hours after end of intratumoral injection.

    For the second and third administration(C1D8 and C1D15),saliva samples for bacterial shedding will be collected within 2 hours prior to the start of SGN1 intratumoral injection, and within 24 ± 3 hours after the end of each SGN1 intratumoral injection.

    In EOT/ET visit, saliva samples for bacterial shedding will be collected.

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

  7. SGN1 level in feces for bacterial shedding.

    In Part 1 and Part 2, feces samples will be collected for Bacterial Shedding.

    For the first SGN1 administration (C1D1), feces sampling for bacterial shedding will be collected by the patient before the intratumoral injection of SGN1,this sample may be collected at any time during the screening period. Additional feces samples will be collected after the end of the intratumoral injection on C1D1 within the time frames below:

    0-24 hours 24-48 hours 48-72 hours

    For the second and third administration(C1D8 and C1D15),feces samples for bacterial shedding will be collected by the patient within 24 hours prior to the start of each SGN1 intratumoral injection, and within 24 hours after the end of each SGN1 intratumoral injection.

    In EOT/ET visit, feces samples will be collected by the subject within 24 hours prior to the EOT/ET visit.

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

  8. Proinflammatory cytokines

    Blood samples will be collected to assess proinflammatory cytokines including IL-1β, IFN-γ, TNF-α, IL-6 and IL-8.

    Measured: Within 7 days prior to first dosing, and at 2, 4, 6, and 24 hours post end of first infusion.

  9. Assessment of tumor colonization

    For superficial tumors, biopsy puncture tissue samples or tissue samples within the last half year will be collected from patients (if lesions are appropriate and patients agree) during the screening period, and tissue samples will be collected, and after the intratumoral injection, tissue biopsy puncture will be performed in pre-dose of the C2D15 (within 2 days).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2021
  2. Study start19 Apr 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study will be conducted in 2 parts: Part 1 is a phase I open-label, dose escalation study phase. Part 2 is as a part of a phase Ib/IIa study, which is a specific Tumor-type expansion study. 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.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05103345
Sponsor's protocol ID
SGN-P01-002
Status last verified
Aug 2026
First submitted
24 Sep 2021
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SGN1 in people with Advanced Solid Tumor, run by Guangzhou Sinogen Pharmaceutical Co., Ltd at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edwin chen ((+86)13427504628, chenhd@sinogen.cc), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: From receiving study drug and throughout the study, until 28 days after the last dosing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05103345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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