230 Participants Needed

DZD8586 for Non-Hodgkin's Lymphoma

Recruiting at 5 trial locations
ZL
Overseen ByZiyi Liu
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 an experimental drug called DZD8586 for individuals with B-cell Non-Hodgkin's Lymphoma (B-NHL) who have not found success with other treatments. The main goals are to identify any side effects, determine how long the drug remains in the body, and assess its effectiveness in treating the cancer independently. The study seeks participants with confirmed B-cell lymphoma that has recurred or not responded to treatment and who maintain a stable health condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that certain therapies and treatments must be stopped for specific periods before starting the trial, such as small molecule therapies and monoclonal antibodies. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that DZD8586 is likely to be safe for humans?

Research has shown that DZD8586 is generally safe based on previous studies. In these studies, patients with B-cell Non-Hodgkin's Lymphoma (B-NHL) tolerated DZD8586 well, and the treatment demonstrated positive effects against tumors. Importantly, side effects were manageable, with few serious issues. Most side effects were mild, suggesting the treatment is relatively safe. Overall, the evidence indicates that DZD8586 is a good option for patients who haven't had success with other treatments.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Non-Hodgkin's Lymphoma, which typically include chemotherapy and monoclonal antibodies, DZD8586 is unique because it targets the disease at a molecular level with a novel mechanism of action. This investigational drug aims to interfere with specific pathways that contribute to cancer cell growth and survival, potentially offering a more targeted and effective approach. Researchers are excited about DZD8586 as it could offer a new way to combat this type of lymphoma, especially for patients who have not responded well to existing therapies.

What evidence suggests that DZD8586 might be an effective treatment for Non-Hodgkin's Lymphoma?

Research has shown that DZD8586, the investigational treatment in this trial, may help treat B-cell Non-Hodgkin's Lymphoma (B-NHL). In a previous study, 64.7% of patients experienced tumor reduction or disappearance with this treatment. One patient even achieved complete recovery after other treatments failed. DZD8586 targets two proteins linked to cancer, which might explain its effectiveness. Early results also indicate that it is safe and works well in the body. These findings suggest DZD8586 could be a promising option for those who haven't had success with other treatments.12456

Who Is on the Research Team?

TZ

Tianwei Zhang

Principal Investigator

Dizal Pharma

Are You a Good Fit for This Trial?

This trial is for adults over 18 with B-cell Non-Hodgkin Lymphoma (B-NHL) that has come back or didn't respond to previous treatments. They should be relatively active and stable in the last two weeks, have good bone marrow and organ function, and agree to follow birth control rules during the study.

Inclusion Criteria

I can care for myself and my physical condition hasn't worsened in the last 2 weeks.
I am willing to follow the study's birth control requirements.
My B-cell lymphoma diagnosis is confirmed by lab tests.
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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 DZD8586 to evaluate safety, tolerability, pharmacokinetics, and anti-tumor efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DZD8586
Trial Overview The trial is testing DZD8586 as a single therapy on patients with B-NHL who haven't had success with other treatments. It aims to understand side effects, how much of the drug stays in the body, and its effectiveness against cancer.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: DZD8586Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dizal Pharmaceuticals

Lead Sponsor

Trials
27
Recruited
2,500+

Citations

Phase 1/2 Studies of DZD8586, a Non-Covalent BBB ...One out of 2 patients with prior Bcl-2 inhibitor treatment achieved complete response. As of the data cut-off date, the longest responder was on ...
Dizal Presents Latest Data of DZD8586, a LYN/BTK Dual ...DZD8586 demonstrated encouraging anti-tumor activity with manageable safety and favorable pharmacokinetic (PK) characteristics in patients with B-NHL.
Phase 2 study of DZD8586, a non-covalent BBB penetrant ...Preclinical evidence showed that this dual-targeting approach significantly improved DZD8586's antitumor efficacies in a range of tumor models ...
NEWS DETAILPhase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade ...
DZD8586 Demonstrates Responses Across Dose Levels ...A total of 17 patients were evaluable for efficacy. The objective response rate (ORR) was 64.7% (n = 11) across all dose levels examined; this ...
DZD8586 in Patients With Relapsed or Refractory B-cell ...Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
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