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Advanced Solid TumorPhase 1/2NCT05038150

Study of SGN1 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 9 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
Search all trials

Trial 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. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
9 sitesin 2 countries
Study dates
16 Jan 2023to 31 Aug 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

  • Patients must meet all the following inclusion criteria:
  • 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.
Show all 23Show fewer
  • 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;
  • International standardized ratio of coagulation function (INR) ≤1.5 × ULN, activated partial thromboplastin time (APTT) ≤1.5 × ULN (If patient has concomitant medication with anticoagulants, whether the coagulation function is qualified will be determined by 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 last dose of drug infusion.
  • Male patients of reproductive capacity must agree to use effective contraception from start of mobilization through at least 6 months after last dose of drug infusion.
  • Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy (HBV DNA test is less than 2000 IU/ml) should be on a suppressive antiviral therapy prior to initiation of cancer therapy. Patients with a history of HCV infection should have completed curative antiviral treatment and HCV viral load below the limit of quantification. Patients with HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible. Patients on concurrent HCV treatment should have HCV below the limit of quantification.
  • 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 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.).
Show all 27Show fewer
  • 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.
  • Those who had received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy that ended fewer than 4 weeks before the first dose of study treatment (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 active or uncontrolled infection or fever, > 38.5℃, of unknown cause during screening or before the first administration of the study drug (according to the judgment of the researcher, fever caused by tumor can be included).
  • Positive for the presence of human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) (positive antigen/antibody and nucleic acid tests); or follow standard of care for HIV diagnosis.
  • Patients with Anti-TP positive.
  • 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.
  • Vaccination within 28 days of the first trial treatment, except for administration of inactivated vaccines and RNA vaccines (e.g., inactivated influenza vaccines and COVID-19 RNA vaccines).
  • Received live or attenuated vaccines within 4 weeks of study drug administration, during treatment, or within 5 months of the last administration.
  • 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 14.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.
  • In the researcher's judgment, patients who are not suitable for other reasons.
  • Documented salmonella infections within 6 months.
  • 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.
  • Patients with implants such as pacemakers, prosthetic cardiac valves, or metal orthopedic prostheses (not include vascular implants for Part 3).

Trial locations and contacts

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

huode chen contact

+86 13427504628

chenhd@sinogen.cc

Weiyun Jia contact

(+86) 13810385484

Weiyun.Jia@pharmaron.com

9 sites in 2 countries

China5 sites, 5 recruiting

  • Changsha Kexin Cancer Hospital

    Changsha, Hunan, 410006

    Tian Tang, 86 15111264138, 164122966@qq.com

    Not yet recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Li Zheng, MD, +86 15030101529, lzheng2005618@163.com

    Recruiting

  • Guangdong Clifford Hospital

    Guangzhou, Guangdong, 511495

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

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yanqiao Zhang, MD, +86 15663676207, yanqiaozhang@126.com

    Recruiting

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

    Haiyan Hu, +86 18930174575, xuri1104@163.com

    Recruiting

Other trials in China

United States4 sites

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267

    Suspended

  • Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

    Detroit, Michigan, 48201

    Withdrawn

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Suspended

  • Health Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Suspended

Other trials in United States

About this study

Official title: Phase I/IIa, Open-label Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Modified Salmonella Typhimurium SGN1 in Patients With Advanced Solid Tumor

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.

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 3 parts:

Part 1 \& 2 is an open-label, dose escalation phase. Part 1 is the DLT observation period, and the patients will enter part 2 for extension treatment after completing the DLT observation period.

Part 3 is an open-label, dose expansion phase. In part 2, the treatment may be terminated if the patients withdraws, has unacceptable toxicity, develops disease progression, experiences an AE that cannot be resolved with/without rescue medication and cause stopping study drug for 2 planned administrations, death, or loss to follow-up. In such cases, patients will be discontinued and palliative or rescue therapy will be offered to those that terminate early.

In part 3, there will be at least 2 tumor types selected, expand between second to four dose level in each tumor type.The Part 3 (Dose expansion stage study) could be started according to the SMC evaluation, do not need waiting the completion the whole cohort of dose escalation (Part 1).

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

    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.

Study groups in NCT05038150
Study groupRoleWhat they receive
CohortExperimentalIn 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 .
Receives: Drug: SGN1

What is being measured

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

  1. 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.

    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
    • 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.

    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 and Choi, mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by 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 and Choi , mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.

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

  5. 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.

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

Secondary outcomes (10)

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

    Any of the following judged to be associated with SGN1 (i.e., possibly-, probably-, or definitely related to), 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 optimal supportive care (OSC).
    5. Hematological toxicities:
    6. Grade 4 hematologic toxicity 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. Incidence with adverse events and preliminary efficacy data to determine the OBD.

    OBD will be determined by adverse events, preliminary efficacy data,and the OBD determined by the SMC.

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

  3. PK analysis of SGN1 level in blood.

    Concentrations of SGN1 will be measured. In Part 1 and Part 3, blood sampling for pharmacokinetics analyses will be conducted. The blood collection times for PK are within 30 minutes Pre-dose and immediately end of injection of first 4 infusions (C1D1, C1D8, C1D15 and C1D22);for first and fourth infusion(C1D1 and C1D22) extra blood sample needs to be collected at the following timepoints after the end of infusion procedure: 15 minutes (± 3 minute), 30 minutes (± 3 minute), 45 minutes (± 3 minute), 1 hour (± 5 minutes), 1.5 hours (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes) and every 30 minutes (± 3 minute) during the infusion procedure, besides, after the start time of infusion, following PK timepoints:24 hours ± 1 hour, 48 hours ± 1 hour and 72 hours ± 1 hour for C1D1 and C1D22.PK blood sampling points may be modified based on patients' PK parameters in future.

    Measured: For the first four infusions in Part 1 and Part 3

  4. Bacterial shedding of SGN1 level in blood.

    In Part 1 and Part 3 ,SGN1 blood concentrations before and after the first SGN1 infusion are measured in the PK Analysis described above. The qPCR results from PK blood samples will contribute to the analysis as the bacterial shedding of SGN1 in blood.

    For subsequent SGN1 infusions (starting with Dose 2),blood samples shall be collected within 2 hours prior to the start of SGN1 infusion and 24 hours±3 hours post end of infusion.

    If blood samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD). If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.

    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. Bacterial shedding of SGN1 level in urine.

    In Part 1 and Part 3, for the first SGN1 administration (C1D1), urine sampling for bacterial shedding will be conducted within 2 hours before administration, 3 hours ±1 hour, 6 hours ±1 hour, 24 hours ±3 hours, 48 hours ±3 hours and 72 hours ±3 hours after end of infusion.

    For subsequent SGN1 infusions (starting with Dose 2), urine samples shall be collected within 2 hours prior to the start of SGN1 infusion and within 24 hours ±3 hours post end of infusion.

    If urine samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD). If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.

    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. Bacterial shedding of SGN1 level in saliva.

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

    For subsequent SGN1 infusions (starting with Dose 2), saliva samples shall be collected within 2 hours prior to the start of SGN1 infusion and within 24 hours ±3 hours post end of infusion. If saliva samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD). If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.

    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. Bacterial shedding of SGN1 level in feces.

    Feces samples for bacterial shedding will be collected by the patient before first administration of SGN1; this sample may be collected at any time during the screening period. Additional feces samples are to be collected after the end of the first infusion within the time frames below.

    0-24 hours 24-48 hours 48-72 hours For subsequent SGN1 infusions (starting with Dose 2), will be collected by the subject within 72 hours prior to infusion and within 72 hours after the end of infusion.

    If feces samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD).If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.

    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. Anti-Drug antibody (ADA) of SGN1.

    Collecting of anti-drug antibodies (ADA) blood samples from all patients.

    Blood samples will be collected before the each administration (within 2 days) for first 2 cycles and first administration of 3rd cycle (C1D1~C3D1) and 24 hours (± 6 hours) post infusion for cycle 1 and cycle 2 (C1D2~C2D23), and at the end of treatment/withdrawal visit.

    The Subsequent ADA blood samples collection timepoints will be adjusted according to the subject's ADA analysis result.

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

  9. Assessment of tumor colonization.

    For appropriate superficial tumors, colonization of the tumor by SGN1 will be assessed by fine needle aspiration and/or excise biopsies every 8 weeks.

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

  10. Proinflammatory cytokines

    Proinflammatory cytokines including IL-1β, IFN-γ,TNF-α, IL-6, and IL-8.

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

Timeline

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

  1. First posted8 Sep 2021
  2. Study start16 Jan 2023
  3. Primary completion18 Jan 2028 (estimated)
  4. Study completion31 Aug 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
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.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038150
Sponsor's protocol ID
SGN-P01-001
Status last verified
Oct 2026
First submitted
24 Aug 2021
Last updated
28 Oct 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 9 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 23 inclusion and 27 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China, United States. 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 huode 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 and severity of AEs (adverse events). (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 NCT05038150.

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 28 Oct 2026.

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