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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.

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

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.

Shuchang Jiang contact

+86 13552250017

shuchang.jiang@hotgen.com.cn

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

Other trials in China

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.

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 groups in NCT07811037
Study groupRoleWhat they receive
SGT003ExperimentalUse SGT003 for Injection
Receives: Drug: SGT003

What is being measured

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

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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)

  1. 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

  2. Peak concentration (Cmax)

    peak concentration

    Measured: From first study treatment to EOT, average of 24 months

  3. Time to peak concentration(Tmax)

    time to peak concentration

    Measured: From first study treatment to EOT, average of 24 months

  4. 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.

  1. First posted9 Sep 2026
  2. Study start17 Aug 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (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
Masking
None (open label)
Enrolment
332 participants (estimated)
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

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?

On the ClinicalTrials.gov record for NCT07811037.

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.

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