← Back to Search

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

Summary

This trial is testing a new drug, HB0025, for people with cancer who have no other treatment options. Up to 154 people will be enrolled. The trial will assess safety, how well the drug works, and side effects.

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.Check my eligibility
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.See study design
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
Select...
My liver cancer cannot be removed by surgery and has been confirmed.
Select...
I have an advanced solid tumor and standard treatments haven't worked or I couldn't tolerate them.
Select...
My kidney function tests are within the required range.
Select...
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.
Select...
I have an advanced cancer and standard treatments haven't worked or I couldn't tolerate them.
Select...
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:
Select...
I have had severe side effects from previous immune treatments that made me stop the treatment.
Select...
My diabetes is not under control, with an A1c over 8%.
Select...
I have had a stem cell, bone marrow, or organ transplant.
Select...
My high blood pressure is not controlled even with treatment.
Select...
My urine protein levels are suitable for the study.
Select...
I have been treated with both a PD-1 inhibitor and a VEGF inhibitor at the same time.
Select...
I agree to use birth control during and for 3 months after treatment.
Select...
I need constant oxygen support or have severe breathing problems.
Select...
I have a wound or fracture that has not fully healed.
Select...
I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.
Select...
I haven't taken immune modulators like cyclosporine or tacrolimus in the last 2 weeks.
Select...
I have brain metastases causing symptoms.
Select...
I have not had another cancer within the last 5 years.
Select...
I have a history of lung scarring or inflammation not caused by infection.
Select...
I haven't had cancer treatment or radiation in the last 4 weeks.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy assessment in dose-expansion phase
Safety assessment in dose-escalation phase
Secondary outcome measures
ADA assessment in dose-escalation phase
ADA assessment in dose-expansion phase
DCR assessment in dose-escalation phase
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HB0025Experimental Treatment1 Intervention
HB0025 IV every 2 weeks (q2w)

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.

Find a Location

Who is running the clinical trial?

Huabo Biopharm Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
599 Total Patients Enrolled

Media Library

Tumors Clinical Trial 2023: HB0025 Highlights & Side Effects. Trial Name: NCT04678908 — Phase 1
~36 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top