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NCT05864573 | ACTIVE NOT RECRUITING | Advanced Solid Tumors

Study of ZGGS15 in Patients With Advanced Solid Tumors
Sponsor:

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:

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

Condition or disease

Advanced Solid Tumors

Intervention/treatment

ZGGS15

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 22 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZGGS15 in Patients With Advanced Solid Tumors
Actual Study Start Date : 2023-07-19
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study of ZGGS15 in Patients With Advanced Solid Tumors

Location Details

NCT05864573

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Zhejiang

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China,