Actively Recruiting
Study of HX044 Drug in Patients with Advanced Solid Tumor Cancers Evaluating Safety, Dosage, and Early Effects in First Human Use
Led by Hanx Biopharmaceuticals (Wuhan) Co., Ltd. · Updated on 2025-01-14
100
Participants Needed
3
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and initial effectiveness of HX044, an investigational drug, in patients with advanced solid tumor malignancies. This Phase I/IIa, first-in-human study aims to find the maximum tolerated dose and recommended dose for Phase 2 while monitoring any early anti-tumor effects. HX044 has been tested in animals with minimal side effects but has not yet been approved by the FDA or other authorities for commercial use. Participants will receive HX044 through a conventional dose-escalation design with treatment given every three weeks. Dose increases depend on the absence of dose-limiting toxicities after 21 days, reviewed by a safety committee. Patients may continue treatment until intolerable side effects occur, disease progresses, they withdraw consent, start new cancer therapy, or reach 24 months on study, whichever happens first. During the study, researchers will closely monitor participants for adverse events up to 90 days after their last dose and assess dose-limiting toxicities by the end of the second treatment cycle. Participants will undergo regular safety and health evaluations, including laboratory tests to check organ function. The trial will include adults aged 18 to 75 years with advanced solid tumors that have not responded to or lack standard treatments, and who have measurable or evaluable tumors.
CONDITIONS
Official Title
HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visits
- Male or female subjects aged 18 to 75 years, inclusive
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed advanced malignant solid tumor refractory or relapsed after standard therapies, or no effective standard therapy available, or refusal of standard therapy
- At least 1 measurable tumor (Phase I allows evaluable tumors without measurable lesions at first 2 dose levels; Phase IIa requires measurable tumor lesions) according to RECIST v1.1
- Life expectancy of at least 12 weeks
- Adequate organ function as indicated by laboratory values: Hemoglobin ≥90 g/L, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥100×10^9/L
- Hepatic function: Serum total bilirubin ≤1.5× upper limit of normal (ULN) or direct bilirubin ≤ULN if total bilirubin >1.5× ULN
- ALT and AST ≤2.5× ULN (≤5× ULN for subjects with liver metastases)
- Renal function: 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, must be within normal range)
You will not qualify if you...
- History of prior malignancy active within the previous 5 years except for the tumor under study and certain cured cancers such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of cervix or breast
- Receipt of anticancer therapy including chemotherapy, radiation, investigational drugs, endocrine therapy, or immunotherapy within 4 weeks before first dose or 5 half-lives, whichever is shorter
- Severe cardiovascular diseases including symptomatic congestive heart failure (NYHA class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, recent myocardial infarction (within 6 months), arterial thromboembolic event or pulmonary embolism (within 3 months)
- QT/QTc interval prolongation over specified limits or use of medications prolonging QT/QTc interval or family history of long QT syndrome
- Active autoimmune disease within 2 years or high relapse risk except stable type I diabetes, autoimmune hypothyroidism on hormone replacement, or mild skin diseases not requiring systemic treatment
- Major surgery within 4 weeks before first dose (except diagnostic surgery) or anticipated need for major surgery during study
- Lung diseases such as interstitial lung disease, pneumonia, pulmonary fibrosis, acute lung disease, or interstitial pneumonia (well-controlled COPD allowed)
- Primary CNS malignancies or symptomatic CNS metastases or certain brain/spinal cord conditions unless stable for at least 3 months after prior treatment
- Use of live vaccines within 4 weeks before first dose
- History of psychotropic substance abuse unable to quit
- Uncontrolled illnesses including cardiovascular, cerebrovascular diseases, diabetes, high blood pressure, or other severe acute or chronic medical or psychiatric diseases or lab abnormalities increasing study risk or interfering with results
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Not Yet Recruiting
2
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
3
Cabrini Health Limited
Malvern, Victoria, Australia, 3144
Actively Recruiting
Research Team
S
Shuang Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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