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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 12 months
Awards & highlights
Summary
This trial is testing an IV drug called HCB101 in adults with advanced cancers or certain types of lymphoma that haven't responded to other treatments. The goal is to see if HCB101 can help shrink tumors and to find the safest and most effective dose. Researchers will also monitor for any side effects.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors or non-Hodgkin lymphoma that's resistant to standard treatments. Participants must have measurable disease, be in fair health (ECOG 0-2), and able to provide tissue samples. They should not have had recent major surgery, untreated side effects from past treatments (except hair loss/anemia), blood transfusions within the last month, or certain other medical conditions.
What is being tested?
The study tests HCB101, an IV drug targeting the SIRPα-CD47 pathway in patients with various advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma. The goal is to determine its effectiveness and safety profile.
What are the potential side effects?
Potential side effects of HCB101 may include allergic reactions to its components, issues related to blood such as anemia if previously present, and possibly other common chemotherapy-related side effects like fatigue, nausea, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of subjects with MTD of HCB101
Number/incidence and percentage of subjects with adverse events, including ADA.
Secondary study objectives
Area under the plasma concentration versus time curve (AUC) of HCB101
Disease Control Rate (DCR)
Duration of Response (DoR)
+5 moreOther study objectives
CD47 receptor occupancy on circulating red blood cells (RBCs)
Concentration of potential PD biomarkers in participants will be assess.
ctDNA detection
Trial Design
1Treatment groups
Experimental Treatment
Group I: HCB101Experimental Treatment1 Intervention
HCB101 in subjects with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
Dosage levels: 0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.64 mg/kg, 1.28 mg/kg, 2.56 mg/kg, and 5.12 mg/kg sequentially.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include targeted therapies and immunotherapies. Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib), work by inhibiting key enzymes involved in the proliferation and survival of lymphoma cells.
Immunotherapies, such as monoclonal antibodies (e.g., rituximab), target specific antigens on the surface of cancer cells, marking them for destruction by the immune system. Additionally, newer treatments like chimeric antigen receptor (CAR) T-cell therapy modify a patient's T-cells to better recognize and attack lymphoma cells.
These mechanisms are vital for NHL patients as they offer more precise and effective ways to combat the disease, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
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Who is running the clinical trial?
FBD Biologics LimitedLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving or have received a cancer treatment that is experimental or approved.I haven't needed treatment for another cancer within the last 2 years.I do not have active or untreated brain metastases or carcinomatous meningitis.I can provide samples of my tumor for testing.I am not using warfarin but may be on other blood thinners.I have a known bleeding condition.I have hepatitis B, active hepatitis C, HIV, or tuberculosis.My side effects from previous treatments have mostly gone away, except for hair loss and low blood count.I can take care of myself and am up and about more than half of my waking hours.I was diagnosed with hemolytic anemia or Evans Syndrome in the last 3 months.I have received treatments targeting the CD47 or SIRPα pathway.I have a serious heart condition.I have at least one tumor that can be measured.My non-Hodgkin lymphoma can be measured or assessed for treatment response.I haven't had major surgery or certain types of radiotherapy within the last 2 weeks.I have received a red blood cell transfusion in the last 4 weeks.I am 18 years old or older.I haven't used any experimental devices within the last 28 days.I have not taken any herbal medications in the last 14 days.My cancer is advanced, doesn't respond to standard treatments, or has come back after 2 treatments.
Research Study Groups:
This trial has the following groups:- Group 1: HCB101
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.
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