A Study of HG381 Administered to Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HitGen Inc.

Criteria

Inclusion Criteria:

• Capable of giving signed informed consent.

• Life expectancy of at least 3 months.

• Histological or cytological documentation of an advanced solid tumor，subjects with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.

• Measurable disease per RECIST version 1.1, there is at least one measurable lesion during the screening period.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

• Adequate organ function : Hematologic system: Hemoglobin ≥9 g/dL, Absolute neutrophil count [ANC] ≥1.5x10^9/L, Platelets ≥100x10^9/L, INR ≤ 1.5 and APTT ≤1.5 x ULN; Hepatic system: Total bilirubin ≤1.5 x ULN, ALT and AST ≤ 2.5 x ULN; Renal system: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated by the Cockcroft-Gault formula); Cardiac system: left ventricular ejection fraction (LVEF) ≥50% ; QT interval (QTcF) ≤470 ms for women, and ≤450 ms for men; Endocrine system: Thyroid-stimulating hormone (TSH) is within the normal limits.

• Subjects with fertility must agree to take medically approved effective contraceptive measures during the entire trial period and at least 3 months after the last medication.

Exclusion Criteria:

• Chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anticancer therapy within 4 weeks.

• Concurrent medical condition requiring the use of other systemic immunosuppressive treatment within 4 weeks before the first dose of study treatment.

• Receipt of any live vaccine within 4 weeks of the start of study treatment.

• Receipt of unmarketed clinical trial drugs or treatments within 4 weeks of the start of study treatment.

• Receipt of surgery or interventional treatment (excluding tumor biopsy, puncture, etc.) within 4 weeks of the start of study treatment.

• History or evidence of cardiovascular and cerebrovascular diseases risk.

• Subjects with uncontrolled diabetes.

• Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment.

• Currently or in the past suffering from malignant tumors.

• Uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently after appropriate intervention.

• Active or suspected autoimmune disease.

• History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.

• Toxicity from previous treatment including: Toxicity Grade ≥3 related to prior immunotherapy and that led to study treatment discontinuation; Toxicity related to prior treatment that has not resolved to Grade ≤ 1.

• Subjects who have acute bacterial, viral or fungal infections and require systemic anti-infective treatment.

• Positive test for syphilis antibodies or human immunodeficiency virus (HIV) antibodies.

• Subjects who are allergic to test drugs and excipients.

• Women who are pregnant or breastfeeding.

• Known drug or alcohol abuse.

• Patients with mental or neurological diseases.

• Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.

• Subjects who have a history of serious systemic disease or any other reason are not suitable to participate in this trial as judged by the investigator.