Clinical trial NCT05864573: Study of ZGGS15 in Patients With Advanced Solid Tumors
Official title: A Phase 1 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZGGS15 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The incidence of dose-limiting toxicities (DLTs)
timeFrame: Up to 21Days
measure: The maximum tolerated dose (MTD)
timeFrame: Up to 24 Months
measure: The recommended dose for subsequent study
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 Months
measure: Duration of response (DOR)
timeFrame: Up to 24 Months
measure: Disease control rate (DCR)
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ji Zhu
role: PRINCIPAL_INVESTIGATOR
References: