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HB0045 Injection for Solid Tumors
Phase 1 & 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will evaluate the safety, effectiveness, and side effects of a new cancer drug for advanced, treatment-resistant tumors. Up to 54 people with advanced solid tumors will be enrolled.
Who is the study for?
Adults (≥18 years) with advanced solid tumors like pancreatic, colorectal, or ovarian cancer that have worsened despite standard treatments. They must be physically capable of participating (ECOG 0-1), have measurable tumor lesions, and a life expectancy over 12 weeks. Participants need functioning major organs and no recent surgeries or ileus. Those with controlled hepatitis B/C or HIV may join. Women must test negative for pregnancy and use effective birth control.Check my eligibility
What is being tested?
The trial is testing HB0045 Injection's safety and effectiveness in treating advanced solid tumors. It's an early-stage study (phase I/II) where patients receive the drug over cycles lasting 21 days each to assess how well it works against their cancer and what side effects occur.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different parts of the body, potential toxicity affecting organ function, fatigue, changes in blood counts which could affect infection risk or cause bleeding issues, allergic responses to the injection itself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Maximum Tolerated Dose(MTD)
Phase I: The incidence of Dose-Limiting Toxicities (DLTs) in patients receiving HB0045
Phase II: Objective response rate (ORR)
Secondary outcome measures
Anti-drug antibodies (ADA)
Disease control rate (DCR)
Duration of response (DOR)
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: HB0045Experimental Treatment1 Intervention
HB0045 IV every 3 weeks (q3w)
Find a Location
Who is running the clinical trial?
Huabo Biopharm Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
682 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,078 Previous Clinical Trials
340,801 Total Patients Enrolled
Gabrail Cancer Center ResearchOTHER
2 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened after one treatment, but the study drug may help.I haven't needed systemic therapy for an autoimmune disease in the last 2 years.I have not had another type of cancer in the last 5 years.My cancer has spread to my brain or spinal cord.I am a woman who can have children, tested negative for pregnancy, and will use birth control.I have a specific infection.I have not been treated with drugs targeting CD73 or A2AR before.My organs are working well enough for treatment.I haven't had major surgery or specific treatments recently.I am 18 years old or older.I have not had cancer treatment recently.I am fully active or can carry out light work.My cancer has not responded to or I cannot tolerate standard treatments.I have recovered from side effects of previous cancer treatments, except for certain conditions.I am currently taking a specific dose of corticosteroids.I have recently received or plan to receive a live vaccine.I don't have health issues that could interfere with the study drug's evaluation.I have had heart problems within a specific time.I have HIV with a CD4 count of at least 350 in the last year.I have had severe side effects from previous immune treatments.I have hepatitis B without symptoms or I am cured of hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: HB0045
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolment for this clinical trial still open?
"Contrary to what may be assumed, clinicaltrials.gov reveals that this experiment is no longer in need of participants. Initially posted on August 20th 2023 and last updated on July 5th 2023, there are currently 2,569 other trials actively looking for volunteers."
Answered by AI
What aims does this research endeavor seek to accomplish?
"According to the trial sponsor, Huabo Biopharm Co., Ltd, this research focuses on ascertaining Dose-Limiting Toxicities (DLTs) alongside other secondary objectives over a 36 month period. These include Maximum serum concentration(Cmax), Half-life (t1/2), and time of maximum concentration(Tmax). All of these parameters will be quantified with Phoenix WinNonlin version 8.3 using non-compartmental analysis and ELISA sample concentration analysis."
Answered by AI
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