HCB101 for Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: FBD Biologics Limited

Must not be taking: Vitamin K antagonists, Herbal medications

Disqualifiers: CNS metastases, Cardiovascular condition, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use herbal medications within 14 days before starting the trial. Also, if you are on a vitamin K antagonist like warfarin, you may need to switch to another type of blood thinner.

What evidence supports the effectiveness of the drug HCB101 for cancer treatment?

Research on similar treatments, like the SIRPαFc fusion protein, shows it can help the immune system fight cancer by blocking signals that protect tumor cells. This approach has shown promise in enhancing antitumor responses in various cancers, suggesting potential effectiveness for HCB101. ^{1 2 3 4 5}

What safety data exists for HCB101 or similar treatments?

The research on similar treatments shows that the Fc fusion peptide used in cancer therapy demonstrated targeted release in tumors with minimal leakage to other parts of the body in mice, suggesting it is safe for further clinical investigation. ^{6 7 8 9 10}

What makes the drug HCB101 unique for cancer treatment?

HCB101 is a SIRP-alpha-Fc fusion protein that targets the CD47-SIRPα pathway, a key immune checkpoint in cancer, to enhance the body's immune response against tumors. This drug is unique because it combines the ability to block the immunosuppressive signal with a fusion protein that can potentially improve targeting and reduce side effects compared to other treatments. ^{3 4 11 12 13}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Able to understand and willing to sign the ICF

I can provide samples of my tumor for testing.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB101

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HCB101 intravenous injection in a dose-escalation manner to evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HCB101 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: HCB101 Experimental Treatment 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UT Southwestern Medical Center Dallas, TX

Hematology-Oncology Associates of the Treasure Coast Port Saint Lucie, FL

Carolina BioOncology Huntersville, NC

Greenville Hospital System University Medical Center (ITOR) Greenville, SC

Who Is Running the Clinical Trial?

FBD Biologics Limited

Lead Sponsor

Trials

3

Recruited

260+

Findings from Research

Novel variants of therapeutic antibodies with specific amino acid substitutions in the Fc region can completely eliminate binding to Fc gamma receptors (FcγR) and C1q, reducing the risk of unwanted inflammatory responses.

These variants maintain important properties such as binding to FcRn, manufacturability, stability, and low potential for immunogenicity, suggesting they could enhance the safety and efficacy of therapeutic antibodies and fusion proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fc-engineered antibodies with immune effector functions completely abolished. Wilkinson, I., Anderson, S., Fry, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

DSP107 combines inhibition of CD47/SIRPα axis with activation of 4-1BB to trigger anticancer immunity. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A HER2-specific Modified Fc Fragment (Fcab) Induces Antitumor Effects Through Degradation of HER2 and Apoptosis. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A SIRPαFc Fusion Protein Conjugated With the Collagen-Binding Domain for Targeted Immunotherapy of Non-Small Cell Lung Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

AL008 Enhances Myeloid Antitumor Function by Inhibiting SIRPα Signaling and Activating Fc Receptors. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

In vivo and in vitro activity of an immunoglobulin Fc fragment (Fcab) with engineered Her-2/neu binding sites. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Controlled release of enhanced cross-hybrid IgGA Fc PD-L1 inhibitors using oncolytic adenoviruses. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

A long-acting erythropoietin fused with noncytolytic human Fc for the treatment of anemia. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Fc-engineered antibodies with immune effector functions completely abolished. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The use of Fab-Fc recombinant antibodies for studying the mechanism of triggering the effector activities of immunoglobulins. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Application of the Fc fusion format to generate tag-free bi-specific diabodies. [2010]

11. Switzerland pubmed.ncbi.nlm.nih.gov

HED, a Human-Engineered Domain, Confers a Unique Fc-Binding Activity to Produce a New Class of Humanized Antibody-like Molecules. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Targeting macrophage checkpoint inhibitor SIRPα for anticancer therapy. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

A novel antibody fragment targeting HAb18G/CD147 with cytotoxicity and decreased immunogenicity. [2020]