Advanced Solid TumorPhase 1/2NCT07811037
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SGT003 in people with Advanced Solid Tumor, run by Beijing Sungen Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors. 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?
- SGT003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to Jun 2029
- 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
- Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
- Patients aged 18 to 75 years at the time of ICF signature.
- Study population:
- Phase I (dose-escalation study): Patients with advanced solid tumors confirmed histologically or cytologically, who have failed at least one standard therapy for advanced disease, are intolerant to standard therapy, or have no available standard treatment options.
- Phase IIa (dose-expansion study): Patients with advanced solid tumors who have received at least first-line but not up to third-line standard systemic therapy and experienced disease progression or intolerance to such therapy.
- ECOG 0 or 1.
- Radiographic evidence (CT/MRI, etc.) of disease progression documented during or after the most recent prior treatment.
- Patients must have adequate bone marrow reserve and organ function.
Who cannot join
- Subjects who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunosuppressive therapy or other anti-tumor therapy within 4 weeks prior to the first administration of the investigational product.
- Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
- Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
- Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
- Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.
- Subjects with a history of Grade ≥3 immune-related adverse events (irAEs), hypersensitivity reactions, or Grade ≥2 immune-related myocarditis.
- Subjects with active autoimmune disease or prior autoimmune disease with a risk of recurrence. Exceptions: well-controlled type 1 diabetes, hypothyroidism controlled solely by hormone replacement therapy, and skin diseases that do not require systemic treatment.
- Subjects with current or prior active interstitial lung disease (ILD). Subjects with radiation-induced pulmonary fibrosis that does not require steroid therapy are eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: A Multicenter, Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
Read the detailed description
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- SGT003
- Keywords
- SGT003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGT003Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SGT003 | Experimental | Use SGT003 for Injection Receives: Drug: SGT003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within the first dose cycle (Day1-Day21) of SGT003
Phase I: Maximum Toxicity Dose（MTD）
The MTD is based on the incidence of DLTs
Measured: 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
Measured: 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,
Measured: 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
Secondary outcomes (4)
Area under the plasma concentration-time curve (AUC)
area under the plasma concentration-time curve
Measured: From first study treatment to EOT, average of 24 months
Peak concentration (Cmax)
peak concentration
Measured: From first study treatment to EOT, average of 24 months
Time to peak concentration(Tmax)
time to peak concentration
Measured: 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)
Measured: Starting from the first administration of investigational product until 28 days (+3 days) after EOT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start17 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811037
- Sponsor's protocol ID
- SG-SGT003-101
- Other IDs
- CTR20262751
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07811037
- Acronym / sponsor ID
- SG-SGT003-101
- Conditions
- Advanced Solid Tumor
- Keywords
- SGT003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGT003 | Experimental | Drug: SGT003Use SGT003 for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
- Patients aged 18 to 75 years at the time of ICF signature.
- Study population:
- ECOG 0 or 1.
- Radiographic evidence (CT/MRI, etc.) of disease progression documented during or after the most recent prior treatment.
Key exclusion criteria (8 listed)
- Subjects who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunosuppressive therapy or other anti-tumor therapy within 4 weeks prior to the first administration of the investigational product.
- Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
- Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
- Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
- Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGT003Dosage 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. | Drug | SGT003 |
Primary outcome
Adverse Events (AEs), immune-related Adverse Events (irAEs)
Time frame: First dose up to 28 days (+3 days) after EOT, or prior to initiation of other anti-tumor therapy, whichever occurs first.
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.
Phase I: Dose Limit Toxicity (DLTs)
Time frame: Within the first dose cycle (Day1-Day21) of SGT003
Evaluated at each dose level of SGT003 graded by NCI CTCAE v6.0.
Phase I: Maximum Toxicity Dose（MTD）
Time frame: Within the first dose cycle (Day1-Day21) of SGT003
The MTD is based on the incidence of DLTs
Phase I: Recommended Phase II dose (RP2D)
Time frame: Within the first dose cycle (Day1-Day21) of SGT003
The RP2D is based on the results of safety、PK/PD and preliminary efficacy of SGT003 in the stage of dose escalation
Phase IIa: Objective Response Rate (ORR)
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
The ratio of CR and PR Evaluated by RECIST1.1 and iRECIST,
4 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: From first study treatment to EOT, average of 24 months
Peak concentration (Cmax)
Time frame: From first study treatment to EOT, average of 24 months
Time to peak concentration(Tmax)
Time frame: From first study treatment to EOT, average of 24 months
Immunogenicity
Time frame: Starting from the first administration of investigational product until 28 days (+3 days) after EOT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SGT003 in people with Advanced Solid Tumor, run by Beijing Sungen Biomedical Technology Co., Ltd at 1 site in China.
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 8 inclusion and 8 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Shuchang Jiang (+86 13552250017, shuchang.jiang@hotgen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs), immune-related Adverse Events (irAEs) (time frame: First dose up to 28 days (+3 days) after EOT, or prior to initiation of other anti-tumor therapy, whichever occurs first.). 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?
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 9 Sep 2026.