Your session is about to expire
← Back to Search
Other
HY-0102 for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Shanghai HyaMab Biotech 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 fu period/eos visits every 3 months (± 14 days) after the eot visit for 6 months
Awards & highlights
Study Summary
This trialtests a new cancer drug to see if it's safe, how it works and if it helps treat cancer.
Who is the study for?
Adults with advanced or metastatic solid tumors that have no remaining standard treatments. They must be in relatively good health, with a life expectancy of at least 3 months and adequate organ function. Women of childbearing potential and men whose partners are of childbearing potential must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing HY-0102, an experimental drug given by IV every two weeks for patients with certain types of cancer that have spread and can't be removed by surgery. It's the first time this drug is being tested in humans to see if it's safe and how well it works against these cancers.See study design
What are the potential side effects?
Since this is a first-in-human study, specific side effects are not yet known but may include typical reactions related to intravenous therapy, immune responses due to the nature of monoclonal antibodies, as well as any unforeseen effects on organs or blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fu period/eos visits every 3 months (± 14 days) after the eot visit for 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fu period/eos visits every 3 months (± 14 days) after the eot visit for 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs).
Number of participants with changes in Clinically Significant Vital Sign from baseline
Number of participants with changes in left ventricular ejection fraction (LVEF) from baseline
+3 moreSecondary outcome measures
AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of HY-0102
AUC(inf) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of HY-0102
AUC(tau) [Area under the concentration-time curve in one dosing interval] of HY-0102
+12 moreOther outcome measures
Biomarkers
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
Cohort 1: 0.03 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 2: 0.3 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 3: 1 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Cohort 4: 2 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Cohort 5: 4 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Cohort 6: 10 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HY-0102
2022
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Shanghai HyaMab Biotech Co.,Ltd.Lead Sponsor
3 Previous Clinical Trials
271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already received medications from the same group of drugs.You are allergic to the study drug or any of its ingredients.You don't have any other treatments available that are known to help with your condition.You have tried all available treatments, but they did not work or caused severe side effects.You have fully recovered from any side effects of previous cancer treatments, except for hair loss, mild nerve damage, low white blood cell count, and hormonal imbalances that are being managed with hormone replacement therapy.You have cancer that has spread to your brain and it is causing symptoms. However, if you have cancer that has spread to your brain but you don't have symptoms and you have been stable for at least 4 weeks after treatment, you may still be eligible for the study.You have not had a severe allergic reaction (Grade 3-4) to treatment with another type of medication called a monoclonal antibody.You have experienced severe side effects from previous treatments that were related to your immune system.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
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.
What are the risks of Dose Escalation for patients?
"Dose Escalation was given a score of 1 on our team's estimation because it is a Phase 1 trial. Limited data is available supporting its efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger