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

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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.

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?

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+

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.

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]

Citations

1.

withpower.com

withpower.com/trial/phase-1-refractory-hodgkin-lymphoma-8-2024-dd3d3

HCB301 for Hodgkin's Lymphoma

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11947194/

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% ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06487624?term=AREA%5BConditionSearch%5D(Camurati-engelmann%20disease%20OR%20%22Camurati-Engelmann%20syndrome%22%20OR%20%22%20Camurati-Englemann%20disease%22%20OR%20%22%20diaphyseal%20dysplasia%22%20OR%20%22%20Engelman's%20disease%22%20OR%20%22%20progressive%20diaphyseal%20dysplasia%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=8

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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06487624?term=Solid%20Tumors&viewType=Table&rank=1

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0305737223001408

Antibody based therapies in Hodgkin lymphoma

Outcomes 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 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7944652/

Treatment of very high-risk classical Hodgkin Lymphoma

Treatment was quite well tolerated: the patient maintained a good PS (1) and did not experience infections or require blood transfusions; a CT scan performed ...

7.

mayo.edu

mayo.edu/research/clinical-trials/diseases-conditions/hodgkin-lymphoma-(hodgkin-disease)

Hodgkin Lymphoma (Hodgkin Disease) Clinical Trials

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0959804924012048

Classic Hodgkin Lymphoma: The LYSA pragmatic guidelines

The 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).