Evaluating HG381 for patients with advanced solid tumors

Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of HG381 as Monotherapy in Patients With Advanced Solid Tumors

This study is testing a new treatment called HG381 for people with advanced solid tumors to see if it's safe and how well it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: HitGen Inc. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT04998422 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced solid tumors who have progressed on or are intolerant to all available therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.

How similar studies have performed: While this approach is novel for HG381, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.

Eligibility 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.

Where this trial is running

Chengdu, Sichuan

• HitGen Inc. — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Jianming Xu, M.D — Chinese PLA General Hospital
• Study coordinator: Jie Shen, M.S

Conditions Advanced Solid Tumor