HFB301001 for Advanced Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, HFB301001, to determine its safety and tolerability in people with advanced cancers. The study consists of two parts: the first part identifies a safe dose, and the second part uses that dose to treat various cancer types. It targets individuals who have previously received certain treatments for cancers such as soft tissue sarcoma, melanoma, or head and neck cancer. Participants should have a measurable cancer and a site suitable for a biopsy (a small tissue sample). As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop any systemic anti-cancer therapy and therapeutic radiation therapy at least 2 weeks before starting the study drug. If you are on systemic steroid therapy or immune suppressive therapy, you may also need to stop these medications.
Is there any evidence suggesting that HFB301001 is likely to be safe for humans?
Research has shown that HFB301001 is generally safe and well-tolerated by patients. In a study involving individuals who had undergone multiple cancer treatments, HFB301001 affected the immune system based on the dose given, meaning the impact varied with different drug amounts. Importantly, the study reported no serious or unexpected side effects. These findings suggest that HFB301001 could be a promising and manageable treatment option for patients with advanced cancers.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for advanced cancers, which often includes chemotherapy, radiation, and targeted therapies, HFB301001 is unique because it is administered via intravenous infusions and may offer a new mechanism of action. Researchers are excited about HFB301001 because it could potentially target cancer cells more precisely, reducing damage to healthy cells and possibly leading to fewer side effects. This innovative approach might enhance the effectiveness of treatment and improve the quality of life for patients with advanced cancers.
What evidence suggests that HFB301001 might be an effective treatment for advanced cancers?
Research shows that HFB301001, the treatment under study in this trial, could be promising for treating advanced cancers. Previous studies found it safe and effective in aiding the immune system. Notably, HFB301001 demonstrated a strong ability to fight tumors in animal tests compared to older treatments. This treatment targets a part of the OX40 protein, activating the immune system to attack tumors. Early results suggest that HFB301001 may benefit patients who have already tried many other treatments.13678
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HFB301001 via intravenous infusions on the first day of each 28-day cycle. The number of cycles depends on the disease response.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HFB301001
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive HFB301001 via intravenous infusions
Find a Clinic Near You
Who Is Running the Clinical Trial?
HiFiBiO Therapeutics
Lead Sponsor
Citations
NCT05229601 | A Study of HFB301001 in Adult Patients ...
The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study.
A phase I monotherapy dose escalation study of ...
HFB301001 demonstrates a favorable safety profile, dose-dependent PK and PD immunomodulation, and DCR in heavily pretreated solid tumors.
HFB301001
In preclinical studies, HFB301001 demonstrated superior in vivo anti-tumor activity compared to benchmark first generation. OX40 agonists. • To ...
4.
aacrjournals.org
aacrjournals.org/cancerres/article/81/13_Supplement/1882/667686/Abstract-1882-Clinical-approach-and-biomarkerAbstract 1882: Clinical approach and biomarker strategy for ...
HFB301001 is a novel human IgG1 agonist antibody that binds to a unique epitope on OX40. This allows for agonistic activity that does not compete with the ...
A Dose Escalation Study of HFB301001 (OX40 Agonist ...
The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study.
Phase I Study of HFB301001, a Novel OX40 Agonist ...
Demonstrates more potent in vivo anti-tumor activity than a benchmark OX40 agonist, suggesting potentially superior T cell stimulation5. i) Pharmacological ...
783TiP Phase I study of HFB301001, a novel OX40 agonist ...
The primary objective is to characterize safety and tolerability of HFB301001, and to determine RDE(s) and RP2D. Secondary objectives include pharmacokinetic ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-hfb301001-in-adult-patients-with-advanced-solid-tumorsA Study of HFB301001 in Adult Patients With Advanced Solid ...
The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.