HCB301 for Hodgkin's Lymphoma

Overseen By FBD Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: FBD Biologics Limited

Must not be taking: Vitamin K antagonists, Herbal medications

Disqualifiers: CNS metastases, Cardiovascular condition, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot use certain cancer therapies, vitamin K antagonists like warfarin, or herbal medications before starting the trial. Some medications like low molecular weight heparin may be allowed on a case-by-case basis.

What data supports the effectiveness of the drug HCB301 for treating Hodgkin's Lymphoma?

Brentuximab vedotin, a drug similar to HCB301, has shown effectiveness in treating Hodgkin's Lymphoma by specifically targeting cancer cells, and it is approved for use in certain cases of the disease. Additionally, therapies targeting CD30, like brentuximab vedotin, have demonstrated promising results in treating relapsed or difficult-to-treat Hodgkin's Lymphoma. ^{1 2 3 4 5}

What safety data exists for homoharringtonine (HCB301) in humans?

Homoharringtonine, also known as omacetaxine mepesuccinate, is an FDA-approved drug for chronic myeloid leukemia, indicating it has undergone safety evaluations for human use. It has shown effectiveness in reducing cancer cell growth in studies, but specific safety data for Hodgkin's Lymphoma is not provided in the available research. ^{6 7 8 9 10}

How does the drug HCB301 differ from other treatments for Hodgkin's Lymphoma?

HCB301 is unique because it targets the CD30 molecule on Hodgkin's lymphoma cells, similar to brentuximab vedotin, which is an antibody-drug conjugate that delivers targeted toxicity to these cells. This approach is different from traditional chemotherapy regimens like ABVD or BEACOPP, which do not specifically target CD30. ^{1 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.

Eligibility Criteria

This trial is for adults over 18 with advanced solid tumors or relapsed/refractory classical Hodgkin lymphoma. Participants must have measurable disease, be in good physical condition (ECOG 0-1), provide tissue samples, and have a life expectancy of at least 12 weeks. It's not suitable for those who still have standard treatment options that could work.

Inclusion Criteria

I can provide samples of my tumor for testing.

My doctor expects me to live for at least 12 more weeks.

I can understand and am willing to sign the informed consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HCB301 at escalating doses to evaluate safety, tolerability, and pharmacokinetics

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• HCB301

Trial Overview The study tests HCB301, an IV injected fusion protein targeting PD-L1 and TGF-β, to see if it's effective against various advanced solid tumors and Hodgkin's lymphoma. The focus is on its effectiveness and the side effects in patients without other treatment options.

Participant Groups

Group I: Experimental: 9.6 mg/kg HCB301 Experimental Treatment 1 Intervention

9.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Group II: Experimental: 4.8 mg/kg HCB301 Experimental Treatment 1 Intervention

4.8 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Group III: Experimental: 2.4 mg/kg HCB301 Experimental Treatment 1 Intervention

2.4 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Group IV: Experimental: 15.0 mg/kg HCB301 Experimental Treatment 1 Intervention

15.0 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Group V: Experimental: 1.2 mg/kg HCB301 Experimental Treatment 1 Intervention

1.2 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Group VI: Experimental: 0.6 mg/kg HCB301 Experimental Treatment 1 Intervention

0.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Group VII: Experimental: 0.3 mg/kg HCB301 Experimental Treatment 1 Intervention

0.3 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Who Is Running the Clinical Trial?

FBD Biologics Limited

Lead Sponsor

Trials

3

Recruited

260+

Findings from Research

Brentuximab vedotin, a CD30 antibody-drug conjugate, and PD-1 antibodies like nivolumab and pembrolizumab are highly effective treatments for relapsed and refractory classical Hodgkin lymphoma (cHL), showing promising results in ongoing studies for earlier treatment lines.

These targeted therapies are expected to improve cure rates and decrease long-term toxicity compared to traditional chemotherapy and radiotherapy, potentially transforming the management of cHL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in CD30- and PD-1-targeted therapies for classical Hodgkin lymphoma. Wang, Y., Nowakowski, GS., Wang, ML., et al.[2020]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Brentuximab vedotin: first-line agent for advanced Hodgkin lymphoma. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Advances in CD30- and PD-1-targeted therapies for classical Hodgkin lymphoma. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Development of CD30 CAR-T cells in refractory or relapsed Hodgkin's lymphoma. [2023]

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

Novel agents in the treatment of Hodgkin lymphoma: Biological basis and clinical results. [2018]

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

Hodgkin lymphoma: answers take time! [2021]

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

Homoharringtonine, an approved anti-leukemia drug, suppresses triple negative breast cancer growth through a rapid reduction of anti-apoptotic protein abundance. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Homoharringtonine demonstrates a cytotoxic effect against triple-negative breast cancer cell lines and acts synergistically with paclitaxel. [2022]

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

Targeting Tissue Factor for Immunotherapy of Triple-Negative Breast Cancer Using a Second-Generation ICON. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Indicators of homologous recombination deficiency in breast cancer and association with response to neoadjuvant chemotherapy. [2020]

10. China pubmed.ncbi.nlm.nih.gov

Association between homologous recombination deficiency and outcomes with platinum and platinum-free chemotherapy in patients with triple-negative breast cancer. [2023]

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

New molecular targets in Hodgkin and Reed-Sternberg cells. [2023]

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

Serum levels of soluble CD30 are elevated in the majority of untreated patients with Hodgkin's disease and correlate with clinical features and prognosis. [2017]

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

Serum level of the soluble form of the CD30 molecule identifies patients with Hodgkin's disease at high risk of unfavorable outcome. [2021]

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

Emerging Pharmacotherapy for Relapsed or Refractory Hodgkin's Lymphoma: Focus on Brentuximab Vedotin. [2021]