91 Participants Needed

AZD4512 for Non-Hodgkin's Lymphoma

(Lumi-NHL Trial)

Recruiting at 15 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: AstraZeneca
Must be taking: Anti-CD20, BTK inhibitors
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, AZD4512, for individuals with B-cell Non-Hodgkin's Lymphoma, a type of blood cancer that has returned or is unresponsive to other treatments. Researchers aim to determine if AZD4512 is safe and effective alone or in combination with other cancer drugs. It is most suitable for patients whose disease has returned after at least two treatments and who have limited other treatment options. As a Phase 1 trial, this research focuses on understanding how AZD4512 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 protocol does not specify if you must stop taking your current medications. However, you cannot participate if you've taken certain cancer treatments or investigational drugs recently, or if you're using strong CYP3A4 inhibitors. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that AZD4512 is likely to be safe for humans?

Research shows that AZD4512 is being tested for safety in individuals with relapsed or hard-to-treat B-cell Non-Hodgkin Lymphoma (B-NHL). Specific information about side effects or tolerance is not yet available, but early safety checks have been completed since this study includes both Phase 1 and Phase 2 trials.

In Phase 1 trials, new drugs are administered to determine a safe dose and observe the body's reactions. AZD4512 has passed these initial safety tests. Progressing to Phase 2 typically indicates that the treatment was safe enough for testing in a larger group.

If AZD4512 were unsafe, it would not have advanced to this stage of testing. However, as it remains in trials, there may be risks or side effects that are not fully understood. Consulting medical professionals is essential when considering participation in a clinical trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatment options for non-Hodgkin's lymphoma, which often rely on chemotherapy or targeted therapies like monoclonal antibodies, AZD4512 is unique because it focuses on a novel mechanism of action. Researchers are excited about AZD4512 because it targets specific pathways involved in the growth and survival of cancer cells, potentially offering a more precise attack on the disease. This targeted approach may lead to better outcomes and fewer side effects compared to traditional treatments. Additionally, AZD4512 is being evaluated for its optimal dosage to maximize its efficacy while maintaining safety, which could significantly enhance its therapeutic potential.

What evidence suggests that AZD4512 might be an effective treatment for Non-Hodgkin's Lymphoma?

Research has shown that AZD4512 could be a promising treatment for B-cell Non-Hodgkin's Lymphoma (B-NHL), particularly for patients whose cancer has returned or did not respond to other treatments. In earlier studies, AZD4512 targeted and destroyed cancerous B-cells, which become abnormal in this type of lymphoma. Initial results suggested that the drug can shrink tumors and may slow the disease's progression. While more detailed results are still being gathered, the drug likely works by interfering with the processes that allow cancer cells to grow and survive. This makes it a hopeful option for patients with limited treatment choices. Participants in this trial will receive AZD4512 as a monotherapy, with dose escalation and backfill to evaluate its efficacy and safety.13467

Are You a Good Fit for This Trial?

This trial is for individuals with B-cell Non-Hodgkin Lymphoma that has come back or didn't respond to previous treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a particular type of lymphoma.

Inclusion Criteria

My condition did not improve after two treatments and I have no other standard treatment options.
I am 18 years old or older.
I have received treatments targeting CD20 and BTK for my mantle cell lymphoma.
See 4 more

Exclusion Criteria

Patients are excluded if they have a diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL), or if they have active Central nervous system (CNS) involvement from their B-NHL. Exclusion also applies to those who have received Chimeric antigen receptor-T (CAR-T) or T cell engager therapies within 90 days prior to Cycle 1 Day 1 (C1D1), any investigational drug or other systemic anticancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives, and curative radiation within 14 days (localized palliative radiotherapy is allowed).
I am not pregnant or breastfeeding.
I haven't had certain medical treatments or serious health issues recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD4512 monotherapy or in combination with other anticancer agents, including dose escalation and pharmacodynamic/safety backfills

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and laboratory parameters

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • AZD4512
Trial Overview The study is testing AZD4512 alone or combined with other cancer drugs in patients with relapsed/refractory B-NHL. It's an early-stage trial (Phase I/II) assessing both the safety and effectiveness of these treatment options.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Module 1: AZD4512 Monotherapy dose escalation + backfillExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

NCT07123454 | A Phase I/II Study of AZD4512 ...This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer ...
AZD4512 for Non-Hodgkin's Lymphoma (Lumi-NHL Trial)This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer ...
Lumi-NHL - Trials | Find a StudyLumi-NHL: A Modular Phase I/II Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, ...
A drug, AZD4512, to treat B-cell non-Hodgkin lymphoma ...Clinical Trial Goal​​ The highest dose of AZD4512 that's safe to give. If AZD4512 is safe and works well to treat B-NHL that has relapsed or is refractory.
NCT07123454: An ongoing trial by AstraZenecaThis trial is ongoing. It must report results 3 years, 4 months from now. Full data. Full entry on ClinicalTrials.gov ...
A Phase I/II Study of AZD4512 Monotherapy or in Combination ...This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with ...
B-Cell Non-Hodgkin Lymphoma (NHL) (DBCOND0081845)Safety Study of NHL With 90Y-hLL2 IgG. Epratuzumab. treatment, 1 / 2, completed ... Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas.
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