Evaluating HG381 for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I, first-in-human, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HG381 administered intravenously to patients with advanced solid tumors. The trial includes a dose escalation phase using a traditional 3+3 design, followed by a cohort expansion phase where subjects will receive HG381 at a determined dose level. Approximately 57 participants will be enrolled, with around 42 in the dose-escalation cohort and 15 in the expansion cohort.

Why it matters

Who can join: the full rules

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.

Where it's running

• HitGen Inc.
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Jianming Xu, M.D — Chinese PLA General Hospital
• Study coordinator: Jie Shen, M.S
• Email: jie.shen@hitgen.com
• Phone: +86 2885197385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.