NCT05417321 · Shanghai Huaota Biopharmaceutical Co., Ltd.
A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
What this study is about
It is a Phase I/II, where both patients and doctors know the treatment given, conducted at multiple hospitals Study to Evaluate the Safety, how the drug moves through the body, how the drug affects the body, and effectiveness of HB0036 in Subjects with Advanced Solid Tumors
View original scientific description
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors
Interventions
DRUG
HB0036
Patients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0036 via intravenous infusion. HB0036 IV every 3 weeks (q3w).
Primary outcome measures
Safety and tolerability
Time frame: Up to 12 Months
Number of participants with a Dose Limiting Toxicity (DLT) \[ Time Frame: During the first 21 days \]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug.
MTD
Time frame: Up to 24 Months
MTD or OBD and/or RP2D.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must meet all the following criteria to be eligible for participation in this study: 1. Male or female. Age ≥ 18 years; 2. Phase I: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed all standard therapies known to provide clinical benefit; \[These solid tumors include but not limit to: non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, head and neck squamous cell carcinomas, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, etc.\]; 3. Phase II: Histologically or cytologically documented locally advanced, recurrent or metastatic cancer. There will be several tumor-specific cohorts Advanced non-small cell lung cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic NSCLC; Confirmed availability of representative tumor sp
Where
- Lafayette, Indiana
- San Antonio, Texas
- Spokane, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 3, 2025 · Source of record for eligibility and locations