Study of ZGGS15 in Patients With Advanced Solid Tumors

Zelgen Biopharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Biological: ZGGS15

Study type

Interventional

Funder types

Industry

Identifiers

NCT05864573

ZGGS15-001

Details and patient eligibility

About

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

Enrollment

22 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.