What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as monoclonal antibodies (e.g., rituximab), chemotherapy agents (e.g., bendamustine), and targeted therapies (e.g., idelalisib), often have side effects that include infusion reactions, which can be severe during the first cycle, especially in patients with high white blood cell counts. Other side effects may include increased risk of infections, gastrointestinal issues (nausea, vomiting, diarrhea), hematologic toxicities (neutropenia, thrombocytopenia), and fatigue. Additionally, targeted therapies may cause liver enzyme abnormalities and respiratory issues. These side effects reflect the treatments' mechanisms of action, such as immune modulation and inhibition of cell proliferation.

What prior FDA approvals exist?

Several drugs have been FDA-approved for the treatment of Non-Hodgkin's Lymphoma (NHL) that target cancer cells through various mechanisms. Rituximab, ofatumumab, and obinutuzumab are anti-CD20 monoclonal antibodies that target B-cells, leading to cell death. Idelalisib is a PI3K inhibitor that induces apoptosis and inhibits cell proliferation. Immune checkpoint inhibitors like pembrolizumab and nivolumab modulate the immune response to target cancer cells. These treatments share similarities with the investigational drug HCB101, which targets the SIRPα-CD47 pathway to modulate the immune response against tumors.

What other types of research exist?

Promising novel alternatives to HCB101 for Non-Hodgkin's Lymphoma patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown high efficacy in relapsed or refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which direct T-cells to target and kill lymphoma cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Next-generation BTK inhibitors like zanubrutinib and acalabrutinib, which offer improved efficacy and tolerability profiles. These therapies leverage mechanisms such as immune modulation, targeted cell killing, and inhibition of key signaling pathways in cancer cells.

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Monoclonal Antibodies

HCB101 for Cancer

Phase 1

Recruiting

Research Sponsored by FBD Biologics Limited

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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Other study objectives

CD47 receptor occupancy on circulating red blood cells (RBCs)

Concentration of potential PD biomarkers in participants will be assess.

ctDNA detection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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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.