Study of ZGGS15 in Patients With Advanced Solid Tumors

NCT ID: NCT05864573

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2025-06-26

Brief Summary

This is a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZGGS15

Group Type: EXPERIMENTAL

ZGGS15

Intervention Type: BIOLOGICAL

ZGGS15 for dose escalations are set as 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg, intravenous infusion, once every 3 weeks.

Interventions

ZGGS15

ZGGS15 for dose escalations are set as 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg, intravenous infusion, once every 3 weeks.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Fully understand the study and voluntarily sign the informed consent form;
• Male or female, 18-70 years of age;
• Histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom the available standard treatments failed;
• Must have at least 1 measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Life expectancy ≥ 3 months;
• All adverse events from prior treatment have either returned to baseline or CTCAE v5.0≤Grade 1;
• Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.

Exclusion Criteria

• Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of the central nervous system (CNS) metastases；
• Uncontrollable third cavity effusion requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
• The main organ function meets any of the following criteria within 7 days prior to treatment:

• Hematological function: absolute neutrophil count (ANC) < 1.5 × 10^9/L, platelet (PLT) < 75 × 10^9/L, or hemoglobin (Hb) < 100 g/L;
• Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), ALT and AST ≥ 5×ULN for patients with liver metastases; total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30 g/L;
• Blood cholesterol > 300 mg/dL or > 7.75 mmol/L;
• Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min;
• International normalized ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5×ULN;
• Any other malignancy within 5 years;
• Abnormal thyroid function with clinical symptoms or diabetes, which cannot be controlled by available treatments;
• History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis;
• Previous immune checkpoint inhibitors induced ≥ Grade 2 immune-related adverse reactions in vital organs, including but not limited to myocarditis and central nervous system toxicity; rapidly tumor progressed after previous PD-1 inhibitor treatment;
• Interstitial lung disease, non-infectious pneumonitis, and radiation-induced pneumonia with symptoms and/or requiring steroids for treatment;
• Received prior allogeneic stem cell transplantation or solid organ transplantation;
• Active infection within 1 week before the first administration currently requires systemic anti-infective therapy;
• Known allergy to other mAbs or any antibody excipient, severe allergic reaction to humanized antibodies or fusion proteins, and history of anaphylactoid reaction or other hypersensitivity reactions;
• Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.;
• Patients were deemed unsuitable for participating in the study by the investigator for any reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji Zhu

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZGGS15-001

Identifier Type: -

Identifier Source: org_study_id