50 Participants Needed

HCB301 for Hodgkin's Lymphoma

FC
Overseen ByFBD Clinical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HCB301 for people with advanced solid tumors or Hodgkin's lymphoma that has returned or does not respond to standard treatments. Researchers aim to find the right dose and identify any side effects. Different groups will receive varying doses of HCB301 to determine the most effective one. This trial may suit those who have tried at least two other treatments for Hodgkin's lymphoma without success or have advanced solid tumors with no other treatment options. Participants must have a measurable tumor and be able to provide a sample of their tumor tissue. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that HCB301 is likely to be safe for humans?

Research shows that HCB301 may help slow the growth of cancer cells. Although detailed safety information for Hodgkin's Lymphoma is not yet available, other studies suggest that the treatment might be well-tolerated. In one previous study, patients did not experience infections or require blood transfusions.

Please note, this trial is in its early stages. Researchers are closely monitoring for any side effects and assessing how well participants tolerate the treatment.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about HCB301 for Hodgkin's Lymphoma because it offers a fresh approach compared to existing treatments like chemotherapy and radiation. HCB301 is unique because it targets specific proteins in cancer cells, potentially offering a more precise attack on the tumor with fewer side effects. Additionally, HCB301 is being tested in various dosages, from 0.3 mg/kg to 15.0 mg/kg, allowing researchers to fine-tune its effectiveness and optimize safety. This level of customization and targeted therapy could pave the way for more personalized cancer treatment options.

What evidence suggests that HCB301 could be an effective treatment for Hodgkin's Lymphoma?

Research is investigating HCB301 as a potential treatment for advanced cancers, such as Hodgkin's lymphoma. Early results suggest that HCB301, a type of protein, targets specific molecules that aid cancer growth. This action may enhance the immune system's ability to recognize and combat cancer cells. Although detailed information from human studies remains limited, early lab results appear promising. Ongoing studies, including this trial with various dosage arms, aim to confirm its effectiveness and safety for people.12678

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Experimental: 9.6 mg/kg HCB301Experimental Treatment1 Intervention
Group II: Experimental: 4.8 mg/kg HCB301Experimental Treatment1 Intervention
Group III: Experimental: 2.4 mg/kg HCB301Experimental Treatment1 Intervention
Group IV: Experimental: 15.0 mg/kg HCB301Experimental Treatment1 Intervention
Group V: Experimental: 1.2 mg/kg HCB301Experimental Treatment1 Intervention
Group VI: Experimental: 0.6 mg/kg HCB301Experimental Treatment1 Intervention
Group VII: Experimental: 0.3 mg/kg HCB301Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

FBD Biologics Limited

Lead Sponsor

Trials
3
Recruited
260+

Published Research Related to This Trial

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

Citations

HCB301 for Hodgkin's LymphomaThe 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 ...
Outcomes in patients with classic Hodgkin lymphoma ...The median overall survival from the time of cHL diagnosis (OS-1) was 14.8 years (95% CI: 10.9–20.9 years) and the 10-year OS-1 estimate was 62% ...
An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion ...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 ...
Antibody based therapies in Hodgkin lymphomaOutcomes recently reported from the team are impressive, with an 18-month PFS of 91 %, after a median follow-up period of 30 months [33]. Consolidation therapy ...
Treatment of very high-risk classical Hodgkin LymphomaTreatment was quite well tolerated: the patient maintained a good PS (1) and did not experience infections or require blood transfusions; a CT scan performed ...
Hodgkin Lymphoma (Hodgkin Disease) Clinical TrialsThe purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory ...
Classic Hodgkin Lymphoma: The LYSA pragmatic guidelinesThe resulting rate of CR was 93 % at the end of treatment, with 2-year PFS of 84 % and a good safety profile (42 % of grade III toxicity, mainly neutropenia).
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