Study of ZG0895.HCl in Patients With Advanced Solid Tumors

Trial Title: Study of ZG0895.HCl in Patients With Advanced Solid Tumors

NCT ID: NCT05877664

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ZG0895 Hydrochloride for Injection
Description: The dose escalation of ZG0895.HCl is set as 0.06, 0.12, 0.18, 0.37, 0.75, 1.50, 2.25, 3.00, and 3.75 mg/m^2 groups, subcutaneous (SC) injection once a week (QW)
Arm group label: Part1：Dose Escalation

Other name: ZG0895.HCl

Summary: The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Fully understand the study and voluntarily sign the informed consent form(ICF). - Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female; - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Life expectancy ≥ 3 months. - All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1(except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc). - 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. - For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions. Part 1: - Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). - Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom available standard treatments failed or were intolerable. Exclusion Criteria: - Participants receiving any of the following treatments: 1. Previously treated with systemic TLR7/8 immunomodulators. 2. Any other investigational product treatment within 4 weeks before the first dosing. 3. Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines within 4 weeks before the first dosing. Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effect, and small molecule targeted therapy within 2 weeks (or 5 half-lives, whichever is longer) before the first dosing. 4. Major surgery within 4 weeks before the first dosing for any reason (excluding puncture biopsy), or need to undergo elective surgery during the trial. 5. Potent CYP3A4/5 inducer or inhibitor within 2 weeks prior to administration of the first dose of the study drug. 6. Systemic immunosuppressive drugs within 2 weeks prior to administration of the first dose of the study drug, including systemic corticosteroids (>10 mg/day prednisone or equivalent). 7. Other immunomodulators within 2 weeks prior to administration of the first dose of the study drug, including but not limited to thymosin, interleukin-2 and interferon. - Had CTCAE Grade ≥3 immune-related adverse events (irAE) after receiving immunotherapy. - The main organ function meets any of the following criteria within 7 days prior to the first dosing. （Note: blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy are not allowed within 14 days prior to treatment.) 1. Hematological function: ANC < 1.5×10^9/L, PLT < 75×10^9/L, Hemoglobin (Hb) < 100 g/L. 2. Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN; ALT and AST ≥ 5×ULN for participants with liver metastases; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30 g/L. 3. Creatinine clearance< 75 mL/min. 4. INR > 1.5 or APTT > 1.5×ULN. 5. The urine protein presents positive and the quantitative result of 24-h urine protein ≥ 1 g. - Participants with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence suggesting that the central nervous system metastasis or meningeal metastasis is not well-controlled and is judged by the investigator to be unsuitable for enrollment. - Uncontrollable third cavity effusion (e.g. large amount pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which is judged by the investigator to be unsuitable for enrollment. - Known history of neurological disorders affecting brain functional activities, including epilepsy or dementia. - Severe cardiac-cerebral vascular disease, including but not limited to: 1. Acute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before the first dosing. 2. New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or the lower normal limit. 3. Uncontrollable hypertension (even though the best available treatment is used but systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg). 4. QTcF interval prolongation during the baseline period. - Participants with active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid diseases. - Active infection requiring systemic therapy within 7 days prior to the first dosing; active hepatitis B or hepatitis C, history of immunodeficiency virus (HIV) disease or HIV antibody positive. - Priorly received allogeneic stem cell transplantation or solid organ transplantation. - Known allergy to the ZG0895.HCl or any of its excipients; have severe allergy history (CTCAE Grade ≥ 3), such as severe urticaria, angioedema, severe anaphylaxis, etc. - Females who are pregnant or nursing during the screening period. - The investigators consider that the participants are not suitable to participate in the clinical study for other reasons.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Zhejiang
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Ji Zhu

Start date: August 8, 2023

Completion date: June 2026

Lead sponsor:
Agency: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class: Industry

Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05877664