Testing HX044 in patients with advanced solid tumors

A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies

This study is testing a new drug called HX044 in people with advanced solid tumors to see how well it works and what the right dose is.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 3 sites (Blacktown, New South Wales and 2 other locations)
• Trial ID: NCT06649708 on ClinicalTrials.gov

What this trial studies

This study evaluates HX044, an investigational drug, in patients with advanced solid tumor malignancies. It includes a dose-escalation and dose-expansion component to determine the maximum tolerated dose (MTD) and assess preliminary antitumor activity. Participants will receive HX044, which has shown promise in animal studies with minimal side effects. The study aims to provide insights into the drug's safety and efficacy in humans.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors that have not responded to standard treatments.

Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: While this approach is novel for HX044, similar studies with investigational drugs have shown promise in treating advanced solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visit;
2. Male or female subject aged 18-75 years, inclusive;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Histologically confirmed advanced malignant solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
5. At least 1 measurable tumor (It is acceptable to allow patients with no measurable lesion but evaluable tumor lesion in the first 2 dose levels in Phase I and at least 1 measurable tumor lesion must be present in Phase IIa) according to RECIST v1.1
6. Life expectancy ≥ 12 weeks.
7. Adequate organ function, as indicated by the following laboratory values: •Hematology (no growth factor and blood transfusion are allowed within 14 days before start of first dose study treatment): Hemoglobin ≥90g/L Absolute neutrophil count ≥1.5×109/L Platelet count ≥100×109/L

   * Hepatic: Serum total bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN
   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver metastases)
   * Renal:Serum creatinine ≤1.5 × ULN
   * Coagulation: Prothrombin time/international normalized ratio ≤1.5 × ULN or activated partial thromboplastin time ≤ 1.5 × ULN (for subjects on anticoagulants, prothrombin time or activated partial thromboplastin time must be within the normal range foranticoagulants).

Exclusion Criteria:

1. Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
2. Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.
3. Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent, as follows:

   * QT/QTc interval prolongation (using Fredericia's QT correction formula) at baseline, Female \> 470 ms, Male \> 450 ms;
   * Medications to prolong the QT/QTc interval are currently being taken;
   * Family history of long QT syndrome.
4. Patients with a history of or presently experiencing an active autoimmune disease within 2 years of initiating study drug, or those who are at high risk of relapse ; however, subjects with the following are allowed to enroll:

   * Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic;
   * Only requiring hormone replacement therapy for autoimmune hypothyroidism;
   * Skin disease that does not require systemic treatment such as eczema rash that accounts for \<10% of the body surface, psoriasis without ophthalmic symptoms.
5. Subjects who received any major surgery within 4 weeks before the first dose of study treatment (except for diagnostic surgery), and/or subjects who may require major surgery during the study.
6. Lung diseases such as, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, interstitial pneumonia. Patients with well controlled chronic obstructive pulmonary disease (COPD) are allowed.
7. Subjects with primary central nervous system (CNS) malignancies, symptomatic CNS metastases, symptomatic parenchymal brain leptomeningeal disease or spinal cord compression, except for the following: who has received prior treatment (surgery/radiotherapy) before signing informed consent form (ICF) and is clinically stable for at least 3 months is allowed (prior treatment with corticosteroids are permitted but must stop 14 days before commencing study treatment）
8. Use of any live vaccines within 4 weeks before the first dose of study treatment.
9. A history of psychotropic substance abuse who is unable to quit.
10. Any patient with an uncontrolled illness such as cardiovascular and cerebrovascular diseases, diabetes, high blood pressure, et, and other severe, acute or chronic medical or psychiatric diseases or laboratory abnormalities that, in the Investigator's opinion, may increase the study-related risks or interfere with the interpretation of the findings.

Where this trial is running

Blacktown, New South Wales and 2 other locations

• Blacktown Hospital — Blacktown, New South Wales, Australia (Not_yet_recruiting)
• Icon Cancer Centre Wesley — Auchenflower, Queensland, Australia (Recruiting)
• Cabrini Health Limited — Malvern, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Shuang Liu

Conditions Advanced Solid Tumor Malignancies