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

NCT07811037 | Recruiting Phase 1 DMC

• 2 other identifiers: SG-SGT003-101CTR20262751
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

SGT003

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Area under the plasma concentration-time curve (AUC)

  From first study treatment to EOT, average of 24 months

• Peak concentration (Cmax)

  From first study treatment to EOT, average of 24 months

• Time to peak concentration(Tmax)

  From first study treatment to EOT, average of 24 months

• Immunogenicity

  Starting from the first administration of investigational product until 28 days (+3 days) after EOT.

Other Outcomes (6)

• Phase I. Objective Response Rate (ORR)

  average Up to 24 months

• Phase I and phase IIa. Duration of Response (DOR)

  average Up to 24 months

• Phase I and phase IIa. Disease Control Rate (DCR)

  average Up to 24 months

Study Arms (1)

SGT003

EXPERIMENTAL

Use SGT003 for Injection

Drug: SGT003

Interventions

SGT003 DRUG

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.

SGT003

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sungen Biomedical Technology Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Shuchang Jiang

CONTACT

+86 13552250017; shuchang.jiang@hotgen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 9, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

CN (1)