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Anti-tumor antibiotic
HF158K1 for HER-2 Positive Solid Cancers
Phase 1
Recruiting
Led By Xiaojia WANG
Research Sponsored by HighField Biopharmaceuticals Corporation
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 this should be evaluated during the screening period, on day 1, 8, 15 of each cycle (each cycle is 21 days) , day 1 of each subsequent cycle, at the eot/early withdrawal and safety follow-up.
Awards & highlights
Study Summary
This trial tests a modified injection to treat HER-2 solid tumors; it's designed to improve efficacy while reducing side effects.
Who is the study for?
Adults with advanced solid tumors expressing HER-2 who have not responded to standard treatments or for whom no treatment is available. They must be in relatively good health, with proper organ and bone marrow function, and willing to use contraception. Excluded are those with certain heart conditions, uncontrolled blood pressure, recent major surgeries or serious infections, prior high-dose doxorubicin treatment, brain metastases causing symptoms, or known allergies to similar drugs.Check my eligibility
What is being tested?
The trial tests different doses of HF158K1—a liposome form of doxorubicin combined with a HER2-targeting component—in patients with varying levels of HER-2 expression in their tumors. The goal is to assess the drug's safety profile and preliminary effectiveness at these doses.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss; plus specific concerns due to doxorubicin like heart issues and infusion-related reactions. Allergic responses could also occur given its biological component.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this should be evaluated during the screening period, on day 1, 8, 15 of each cycle (each cycle is 21 days) , day 1 of each subsequent cycle, at the eot/early withdrawal and safety follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this should be evaluated during the screening period, on day 1, 8, 15 of each cycle (each cycle is 21 days) , day 1 of each subsequent cycle, at the eot/early withdrawal and safety follow-up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ALT concentration in whole blood sample
AST concentration in whole blood sample
Activated partial prothrombin time in whole blood sample
+60 moreSecondary outcome measures
AUC by plasma concentration of whole blood sample
AUClast by plasma concentration of whole blood sample
Analysis of immunogenicity
+8 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Dose escalation cohort 1: HF158K1 given Q3W at 60 mg/m²Experimental Treatment1 Intervention
Participants in this dose group(60 mg/m²) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.
Group II: Dose escalation cohort 1: HF158K1 given Q3W at 6 mg/m²Experimental Treatment1 Intervention
Participants in this dose group(6 mg/m²) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.
Group III: Dose escalation cohort 1: HF158K1 given Q3W at 45 mg/m²Experimental Treatment1 Intervention
Participants in this dose group(45 mg/m²) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.
Group IV: Dose escalation cohort 1: HF158K1 given Q3W at 30 mg/m²Experimental Treatment1 Intervention
Participants in this dose group(30 mg/m²) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.
Group V: Dose escalation cohort 1: HF158K1 given Q3W at 2 mg/m²Experimental Treatment1 Intervention
Participants in this dose group(2 mg/m²) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.
Group VI: Dose escalation cohort 1: HF158K1 given Q3W at 15 mg/m²Experimental Treatment1 Intervention
Participants in this dose group(15 mg/m²) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.
Find a Location
Who is running the clinical trial?
HighField Biopharmaceuticals CorporationLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
Xiaojia WANGPrincipal InvestigatorZhejiang Cancer Hospital
MINAL BARVEPrincipal InvestigatorMary Crowley Cancer Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a high dose of doxorubicin or experienced severe heart issues from it.I haven't taken certain medications recently.My blood, liver, and kidney tests are within normal ranges.I have brain metastases causing symptoms.I have a history of serious heart or brain blood vessel diseases.I have wounds or fractures that are not healing.I am not taking medication that strongly affects certain enzymes.I have fluid buildup that can't be managed with treatment.I am currently on IV medication for an infection.I have not had recent major surgery or significant injury.I have a viral infection.I am 18 years or older.I am fully active or can carry out light work.I have at least one tumor that can be measured.My cancer is HER-2 positive or has low HER-2 and cannot be surgically removed or has spread, and standard treatments have not worked or are not suitable for me.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation cohort 1: HF158K1 given Q3W at 60 mg/m²
- Group 2: Dose escalation cohort 1: HF158K1 given Q3W at 6 mg/m²
- Group 3: Dose escalation cohort 1: HF158K1 given Q3W at 2 mg/m²
- Group 4: Dose escalation cohort 1: HF158K1 given Q3W at 15 mg/m²
- Group 5: Dose escalation cohort 1: HF158K1 given Q3W at 30 mg/m²
- Group 6: Dose escalation cohort 1: HF158K1 given Q3W at 45 mg/m²
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 recruitment ongoing for this research project?
"Clinicaltrials.gov data reveals that this clinical trial is no longer recruiting patients, despite the fact it was initially posted on June 16th 2023 and recently updated in May 6th 2023. However, 2555 additional medical studies remain open for patient recruitment at present."
Answered by AI
Has the FDA officially sanctioned a biweekly dosage of 2 mg/m² for group one (HF158K1) under Dose escalation cohort 1?
"Our team at Power assess the safety of Dose escalation cohort 1: HF158K1 given Q3W at 2 mg/m² as a 1, due to this being an early Phase 1 trial with limited data regarding efficacy and safety."
Answered by AI
What are the main aims of this clinical experiment?
"The primary goal of this clinical trial is to assess the incidence of dose-limiting toxicities. Secondary objectives include measuring area under plasma concentration -time curve after dosing, peak time (Tmax) after dosing, and elimination half-life (T1/2) after dose. Data collection will commence once participants receive the investigational drug until 28±3 days following end of treatment or early withdrawal from study, whichever occurs first."
Answered by AI
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