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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 baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective. Patients will be given increasing doses to find the best dose, then be assigned to a group to test how well it works.
Who is the study for?
Adults with advanced solid tumors like sarcoma, melanoma, and various carcinomas who've had at least one line of therapy for their cancer can join. They need measurable disease, good performance status, and a tumor that can be biopsied. Excluded are those on high-dose steroids or immune suppressants, unstable health conditions, recent major surgery or lung issues from drugs.Check my eligibility
What is being tested?
HFB301001's safety is being tested in two parts: first to find a safe dose by gradually increasing it among groups; then using this dose in more people based on their cancer type. The goal is to see how well patients tolerate the drug and its effects on different cancers.See study design
What are the potential side effects?
While specific side effects of HFB301001 aren't listed here, common ones for new cancer treatments may include fatigue, nausea, allergic reactions similar to other monoclonal antibodies or infusion-related reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and ECG parameters, and tolerability (dose interruptions, reductions, and dose intensity)
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Secondary outcome measures
Area under the concentration versus time curve (AUC)
Disease Control Rate (DCR) as determined by RECIST1.1 and iRECIST
Duration of Response (DOR) as determined by RECIST1.1 and iRECIST
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: HFB301001Experimental Treatment1 Intervention
Participants will receive HFB301001 via intravenous infusions
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Who is running the clinical trial?
HiFiBiO TherapeuticsLead Sponsor
4 Previous Clinical Trials
297 Total Patients Enrolled
2 Trials studying Melanoma
253 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It doesn't matter if you have any level of hair loss (alopecia).You have already received at least one type of treatment for soft tissue sarcoma.If you have soft tissue sarcoma, you cannot have received any previous immune therapy or immune agonist antibodies.If you have uterine carcinosarcoma, you should not have received immune therapy before.You have an ongoing autoimmune disease that requires medication to manage in the past 2 years.You have already tried at least two different treatments for head and neck squamous cell carcinoma.You have already tried at least two different treatments for renal cell carcinoma.You have already received treatment for uterine carcinosarcoma at least once.You have already received treatment for hepatocellular carcinoma.You have a specific mutation called BRAF V600E and have already tried at least two different treatments.You have experienced allergic reactions to similar medications or ingredients found in HFB301001.It's okay if you have a hormone imbalance and are taking medication to manage it.You have received any cancer treatment in the past two weeks before starting the study drug.You have received radiation therapy in the last 2 weeks.You have previously received medications that target the OX40 receptor.
Research Study Groups:
This trial has the following groups:- Group 1: HFB301001
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.
How many individuals are being accepted to partake in this experiment?
"HiFiBiO Therapeutics, the trial's sponsor, is running this study at multiple sites including Mayo Clinic in Scottsdale and Dana Farber Cancer Institute in Boston. To move forward with their research objectives they need to recruit 84 suitable participants that meet all of the necessary inclusion criteria."
Answered by AI
Is enrollment currently available for this trial?
"Affirmative. Discernible on clinicaltrials.gov, this examination has been actively recruiting since April 20th 2022 and was recently updated on September 13th of the same year. 84 individuals need to be enrolled across 7 medical facilities in total."
Answered by AI
Has the FDA granted its blessing to HFB301001?
"Considering the lack of data pertaining to efficacy and safety, HFB301001 appears to be relatively low-risk with a 1 score on our rating system."
Answered by AI
How many US locations are conducting this medical experiment?
"The ongoing clinical trial is presently recruiting patients from 7 different medical sites. Notably, these locations are in Scottsdale, Boston and Fairfax as well as several other cities. It is important to pick the closest site to minimize travel requirements if you decide to join the study."
Answered by AI
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