What side effects are associated with this type of intervention?

Common treatments for advanced solid tumors, including novel therapeutic agents like HB0025 and immunotherapies, often have a range of side effects. These can include fatigue, nausea, hyperglycemia, decreased appetite, and diarrhea. Immunotherapies may also cause immune-related adverse events such as rash, pruritus, pneumonitis, and colitis. Additionally, targeted therapies can lead to specific toxicities like skin reactions, hypertension, and liver function abnormalities. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several novel therapeutic agents for the treatment of advanced solid tumors. These include pembrolizumab, an immune checkpoint inhibitor used for various cancers including melanoma and non-small cell lung cancer, and vemurafenib, a BRAF inhibitor for melanoma. Both drugs underwent rigorous clinical trials to evaluate their safety, efficacy, and antitumor activity, similar to the ongoing study of HB0025. These approvals have paved the way for new treatment options in oncology, focusing on targeted therapies and immunotherapies.

What other types of research exist?

Promising novel alternatives to HB0025 for advanced solid tumors in 2024 include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, as seen in the KEYNOTE trials for various cancers. 2) Atezolizumab (Tecentriq) in combination with chemotherapy, particularly for non-small cell lung cancer (NSCLC) and other solid tumors. 3) Niraparib plus nivolumab or ipilimumab for platinum-sensitive advanced pancreatic cancer. 4) Futibatinib for cholangiocarcinoma with FGFR2 fusions/rearrangements. 5) Nivolumab plus ipilimumab for unresectable malignant pleural mesothelioma. These therapies have shown promising results in clinical trials and are expected to be significant in the treatment landscape for advanced solid tumors.

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Virus Therapy

HB0025 Injection for Cancer

Phase 1

Waitlist Available

Research Sponsored by Huabo Biopharm Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

i) Unresectable HCC with diagnosis confirmed by histology/cytology or clinical criteria.

1) Dose escalation phase: Patients with histologically or cytologically confirmed advanced malignant solid tumor who have received or been intolerant of all standard therapies thought to confer clinical benefit. These solid tumors include but are not limited to hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), renal carcinoma (RCC), endometrial carcinoma, etc.

Must not have

History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.

Uncontrolled diabetes mellitus with hemoglobin A1c > 8%.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called HB0025 for patients with advanced solid tumors who have no other treatment options. The study aims to find the safest and most effective dose by adjusting the amount given to patients over time. Researchers will monitor how the drug affects the body and its ability to fight tumors.

Who is the study for?

This trial is for adults with advanced solid tumors that have worsened after standard treatments or when no further beneficial treatment options are available. Participants must be over 18, have a life expectancy of at least 3 months, and good liver function. They should not have severe autoimmune diseases, recent heart attacks or strokes, active infections including COVID-19, or be pregnant.

What is being tested?

HB0025 is being tested in patients with various types of advanced solid tumors to assess its safety and effectiveness. The study involves multiple centers and includes dose escalation (finding the right dose) and expansion (testing it on more people). Patients will receive HB0025 injections every 28 days while researchers monitor their response to the drug.

What are the potential side effects?

While specific side effects for HB0025 aren't listed here, similar cancer drugs can cause immune reactions, fatigue, digestive issues like nausea or diarrhea, skin reactions at injection sites, increased risk of infection due to lowered immunity and potential liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer cannot be removed by surgery and has been confirmed.

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I have an advanced solid tumor and standard treatments haven't worked or I couldn't tolerate them.

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My kidney function tests are within the required range.

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Rewritten Criteria: - You have a low score on the Child-Pugh Classification test. - You do not have the hepatitis B virus or, if you do, you are on medication to control it and your viral load is low.

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I have an advanced cancer and standard treatments haven't worked or I couldn't tolerate them.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe side effects from previous immune treatments that made me stop the treatment.

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My diabetes is not under control, with an A1c over 8%.

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I have had a stem cell, bone marrow, or organ transplant.

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My high blood pressure is not controlled even with treatment.

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My urine protein levels are suitable for the study.

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I have been treated with both a PD-1 inhibitor and a VEGF inhibitor at the same time.

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I agree to use birth control during and for 3 months after treatment.

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I need constant oxygen support or have severe breathing problems.

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I have a wound or fracture that has not fully healed.

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I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.

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I haven't taken immune modulators like cyclosporine or tacrolimus in the last 2 weeks.

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I have brain metastases causing symptoms.

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I have not had another cancer within the last 5 years.

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I have a history of lung scarring or inflammation not caused by infection.

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I haven't had cancer treatment or radiation in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy assessment in dose-expansion phase

Safety assessment in dose-escalation phase

Secondary study objectives

ADA assessment in dose-escalation phase

ADA assessment in dose-expansion phase

DCR assessment in dose-escalation phase

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HB0025Experimental Treatment1 Intervention

HB0025 IV every 2 weeks (q2w)

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tumors include chemotherapy, targeted therapy, immunotherapy, and novel agents. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Targeted therapies block specific proteins or pathways involved in tumor growth, such as HER2 or VEGF, to inhibit cancer progression. Immunotherapy enhances the immune system's ability to recognize and destroy cancer cells. Novel agents, like HB0025, may combine these approaches or introduce new mechanisms, such as targeting unique biomarkers or boosting immune response. Understanding these mechanisms helps in selecting the most appropriate treatment based on the tumor's characteristics and the patient's health.