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 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SGT003

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 Type: Interventional
• Enrollment (Estimated): 332
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shuchang Jiang; Phone Number: +86 13552250017; Email: shuchang.jiang@hotgen.com.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
2. Patients aged 18 to 75 years at the time of ICF signature.

3. 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.
4. ECOG 0 or 1.
5. Radiographic evidence (CT/MRI, etc.) of disease progression documented during or after the most recent prior treatment.
6. Patients must have adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. 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.
2. Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
3. Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
4. Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
5. Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.
6. Subjects with a history of Grade ≥3 immune-related adverse events (irAEs), hypersensitivity reactions, or Grade ≥2 immune-related myocarditis.
7. 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.
8. Subjects with current or prior active interstitial lung disease (ILD). Subjects with radiation-induced pulmonary fibrosis that does not require steroid therapy are eligible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SGT003; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within the first dose cycle (Day1-Day21) of SGT003
Phase I: Maximum Toxicity Dose（MTD）	The MTD is based on the incidence of DLTs	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	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,	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve (AUC)	area under the plasma concentration-time curve	From first study treatment to EOT, average of 24 months
Peak concentration (Cmax)	peak concentration	From first study treatment to EOT, average of 24 months
Time to peak concentration(Tmax)	time to peak concentration	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)	Starting from the first administration of investigational product until 28 days (+3 days) after EOT.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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,	average Up to 24 months
Phase IIa. Overall Survival (OS)	the period from date of randomization to death	average up to 24 months

Collaborators and Investigators

• Sponsor: Beijing Sungen Biomedical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: September 6, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 6, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: SGT003
• Other Study ID Numbers: SG-SGT003-101; CTR20262751 (Registry Identifier: China Center for Drug Evaluation (CDE), NMPA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No