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HB0036 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Phase II: Histologically or cytologically documented locally advanced, recurrent or metastatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug to treat advanced solid tumors. The safety, how well the body absorbs and processes the drug, and how effective the drug is will be studied.
Who is the study for?
Adults with advanced solid tumors, measurable cancer lesions, good performance status (able to carry out daily activities), and proper organ function can join this trial. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent severe allergic reactions to similar drugs, certain heart conditions within the past 6 months, active infections like HIV or hepatitis B/C, other recent treatments or trials, substance abuse issues.Check my eligibility
What is being tested?
The study is testing HB0036's safety and effectiveness in treating advanced solid tumors including non-small cell lung cancer. It's an early-phase trial assessing how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), and its potential benefits.See study design
What are the potential side effects?
While specific side effects of HB0036 are not listed here due to it being an early-stage trial, common side effects for cancer treatments may include fatigue, nausea, inflammation at injection sites, immune system reactions that could affect organs' functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer is advanced, recurrent, or has spread to other parts.
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My cancer is advanced and has not responded to standard treatments.
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I have confirmed I am not pregnant with a test 3 days before starting the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD
Safety and tolerability
Secondary outcome measures
AUC
Cmax
Tmax
Other outcome measures
ORR assessment in dose-escalation phase
Trial Design
1Treatment groups
Experimental Treatment
Group I: HB0036Experimental Treatment1 Intervention
HB0036 IV every 3 weeks (q3w)
Find a Location
Who is running the clinical trial?
Shanghai Huaota Biopharmaceutical Co., Ltd.Lead Sponsor
6 Previous Clinical Trials
253 Total Patients Enrolled
Aijun Qin, MDStudy DirectorShanghai Huaota Biopharmaceutical Co., Ltd.
Yang Yang, MD/PHDStudy DirectorShanghai Huaota Biopharmaceutical Co., Ltd.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception during the trial.I agree to use birth control during and for 3 months after treatment.I have been treated with medication targeting the TIGIT pathway.I am fully active or can carry out light work.I have not received any live vaccines in the last 4 weeks, except for the COVID-19 vaccine.I have taken antibiotics for more than a week in the last month.I have had lung conditions not caused by infections or from radiotherapy.I haven't taken high doses of steroids or immunosuppressants in the last 2 weeks.You have had a transplant of stem cells or organs donated by someone else before.You misuse alcohol, cannabis products or other drugs.I have active cancer spread to my brain or its coverings.I haven't had cancer treatment or radiation in the last 4 weeks.My cancer is advanced, recurrent, or has spread to other parts.I am currently being treated for TB or was treated for TB within the last year.You have not participated in any other clinical trial for a drug or medical device in the past 4 weeks.You have experienced severe allergic reactions to other monoclonal antibodies, or are known to be allergic to protein drugs or certain ingredients in HB0036 drug formulation.I have been treated with specific immune therapy for my cancer.I have recovered from previous cancer treatment side effects, except for hair loss, mild nerve pain, or hormone issues treated with medication.I haven't had a stroke, heart attack, severe chest pain, or serious heart failure in the last 6 months.I have had severe side effects from previous immune treatments, except for manageable hormone issues.My cancer is advanced and has not responded to standard treatments.The investigator has determined that your medical condition makes it inappropriate for you to participate in the study.I am 18 years old or older.My organs are functioning well enough for treatment.I have confirmed I am not pregnant with a test 3 days before starting the study.I haven't had any cancer other than specific non-aggressive types in the last 5 years.You have a medical, mental health, or family condition that may make it difficult for you to follow through with the study plan or put you at risk during treatment.You are expected to live for at least 12 weeks.I haven't needed systemic therapy for an autoimmune disease in the last 2 years, except for certain conditions.I haven't had major surgery or cancer treatment in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: HB0036
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.
Are there any vacancies available for those looking to participate in this experiment?
"The clinical trial, which was initially made public on August 25th 2022 and recently revised on September 14th 2022 is actively recruiting participants. This can be verified through the information available at clinicaltrials.gov."
Answered by AI
What is the capacity of this trial in regards to patient enrollment?
"Confirmed. The details featured on clinicaltrials.gov show that from August 25th 2022, this experiment is actively recruiting patients. 80 individuals are needed to be enrolled at one centre and the information has been recently updated on September 14th 2022."
Answered by AI
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