A Phase 1/2 interventional study of SGT003 in Advanced Solid Tumor, sponsored by Beijing Sungen Biomedical Technology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Beijing Sungen Biomedical Technology Co., Ltd · Phase 1/2, Interventional, and Treatment
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
This is a first-in-human Phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors. The study comprises a Phase I (dose-escalation) stage and a Phase IIa (dose-expansion) stage.
Beijing Sungen Biomedical Technology Co., Ltd is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study population:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use SGT003 for Injection
Drug: SGT003
Dosage Form: Injection Strength: 50 mg (5 mL) per vial Dosage and Administration: Subjects will receive SGT003 (investigational product) via intravenous (IV) infusion on Day 1 (D1) of each cycle. Dose: During the Phase I dose-escalation, subjects will be dosed according to the assigned dose cohort; during the Phase IIa dose-expansion stage, subjects will be dosed according to the selected expansion dose. Duration of Administration: For each subject, the first infusion will be completed within 90 minutes. If no infusion-related reaction (IRR) and/or hypersensitivity reaction occurs, the subsequent infusion duration may be shortened to no less than 60 minutes.
Adverse Events (AEs), immune-related Adverse Events (irAEs)
This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 6.0.
Time frame: First dose up to 28 days (+3 days) after EOT, or prior to initiation of other anti-tumor therapy, whichever occurs first.
Phase I: Dose Limit Toxicity (DLTs)
Evaluated at each dose level of SGT003 graded by NCI CTCAE v6.0.
Time frame: Within the first dose cycle (Day1-Day21) of SGT003
Phase I: Maximum Toxicity Dose（MTD）
The MTD is based on the incidence of DLTs
Time frame: Within the first dose cycle (Day1-Day21) of SGT003
Phase I: Recommended Phase II dose (RP2D)
The RP2D is based on the results of safety、PK/PD and preliminary efficacy of SGT003 in the stage of dose escalation
Time frame: Within the first dose cycle (Day1-Day21) of SGT003
Phase IIa: Objective Response Rate (ORR)
The ratio of CR and PR Evaluated by RECIST1.1 and iRECIST,
Time frame: from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first. average Up to 24 months
Area under the plasma concentration-time curve (AUC)
area under the plasma concentration-time curve
Time frame: From first study treatment to EOT, average of 24 months
Peak concentration (Cmax)
peak concentration
Time frame: From first study treatment to EOT, average of 24 months
Time to peak concentration(Tmax)
time to peak concentration
Time frame: From first study treatment to EOT, average of 24 months
Immunogenicity
ADA detection rate, ADA incidence rate, Nab detection rate (if applicable), Nab incidence rate (if applicable)
Time frame: Starting from the first administration of investigational product until 28 days (+3 days) after EOT.
Phase I. Objective Response Rate (ORR)
Evaluated by RECIST1.1 and iRECIST, from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.
Time frame: average Up to 24 months
Phase I and phase IIa. Duration of Response (DOR)
Evaluated by RECIST1.1 and iRECIST, from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.
Time frame: average Up to 24 months
Phase I and phase IIa. Disease Control Rate (DCR)
The ratio of CR、PR and SD Evaluated by RECIST1.1 and iRECIST, whichever occurs first.
Time frame: average Up to 24 months
Phase I and phase IIa. Time to Response (TTR)
The period from the date of randomization to the occurrence of CR/PR，evaluated by RECIST1.1 and iRECIST, , until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.
Time frame: average up to 24 months
Phase I and phase IIa. Progression-Free Survival (PFS)
from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first. Evaluated by RECIST1.1 and iRECIST,
Time frame: average Up to 24 months
Phase IIa. Overall Survival (OS)
the period from date of randomization to death
Time frame: average up to 24 months
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Beijing Sungen Biomedical Technology Co., Ltd