Study of HB0045 Injection for Patients with Advanced Solid Tumors
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
ClinicalTrials ID:NCT06056323
This clinical trial is testing a new drug, HB0045, to see if it is safe and effective for patients with advanced solid tumors who have not responded to standard treatments. The study will be conducted in two phases, with the first phase focusing on safety and the second phase on effectiveness.
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Program Overview
This study is designed to evaluate the safety and effectiveness of a new drug called HB0045 in patients with advanced solid tumors that have not responded to standard treatments. The study will be conducted in two phases. In Phase I, up to 54 patients will receive HB0045 to determine the safest dose. In Phase II, the drug's effectiveness will be tested in patients with specific types of cancer, such as pancreatic, colorectal, and ovarian cancer. Each treatment cycle lasts 21 days.
Description
In the first phase of the study, researchers will focus on determining the safety and tolerability of HB0045 in patients with advanced solid tumors. This phase will help identify the best dose for further testing. Up to 54 patients will receive the drug in increasing doses over 21-day cycles.
In the second phase, the study will evaluate the effectiveness of HB0045 at the recommended dose in patients with specific cancers, including pancreatic, colorectal, and ovarian cancer. The study will use a two-stage design to determine if the drug is effective. If no responses are observed in the first stage, the cohort will be discontinued. If at least one response is observed, more patients will be enrolled to further assess the drug's effectiveness.
The study aims to provide valuable information on the safety and potential benefits of HB0045 for patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Ability to understand and sign the informed consent form and comply with study procedures.
- Phase I: Patients with advanced solid tumors that have not responded to standard treatments, including but not limited to pancreatic, colorectal, ovarian, breast, lung, head and neck, prostate, renal cancer, and sarcoma.
- Phase II: Patients with specific types of cancer, such as pancreatic, colorectal, and ovarian cancer, who have not responded to at least one previous treatment.
- At least one measurable tumor as defined by standard criteria.
- Good overall health with an ECOG performance status of 0-1.
- Life expectancy of at least 12 weeks.
- Patients with controlled hepatitis B or cured hepatitis C may be eligible.
- Patients with HIV infection and a CD4 count of 350 cells/mm3 or higher may be eligible.
- Adequate organ function as determined by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
- Recovery from previous cancer treatment side effects to a manageable level.
Exclusion Criteria
- Other active cancers within the past 5 years, except for certain non-threatening types.
- Active or untreated brain metastases or cancer spread to the brain lining.
- Recent serious heart problems or uncontrolled heart rhythm issues.
- Active autoimmune diseases requiring treatment within the past 2 years, except for certain conditions like hypothyroidism or diabetes.
- Previous organ or stem cell transplants.
- Severe allergic reactions to similar drugs.
- Recent use of high-dose steroids or other immunosuppressive drugs.
- Recent long-term antibiotic use or live vaccines.
- Active infections like COVID-19 or tuberculosis.
- Previous treatment with drugs targeting CD73 or A2AR.
- Recent participation in other clinical trials or treatments.
- Any condition that may interfere with the study or pose a high risk to the patient.
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