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Virus Therapy

HB0025 Injection for Cancer

Phase 1

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study 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

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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.

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

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)

0 / 6Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been included in this clinical research?

"Affirmative. According to the info on clinicaltrials.gov, this experiment is currently recruiting volunteers and was originally posted on March 10th 2021 with an update made recently in May 31st 2022. A total of 154 participants are needed from one location."

Answered by AI

What evidence is there that demonstrates the safety of HB0025 for individuals?

"Due to the minimal evidence regarding its efficacy and safety, HB0025 has been assigned a score of 1."

Answered by AI

Are volunteers still welcome to participate in this testing program?

"According to the data available on clinicaltrials.gov, this research is currently looking for participants. It was initially published on March 10th 2021 and most recently revised on May 31st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Injection HB0025 in Patients With Advanced Solid Tumors

2021. "A Study of Injection HB0025 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678908.