AZD4512 for Acute Lymphoblastic Leukemia

(ALLight Trial)

Not yet recruiting at 18 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: QTc prolonging, CYP 3A4 inhibitors

Disqualifiers: Burkitt lymphoma, CNS involvement, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD4512 for individuals with relapsed or refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL). Researchers aim to determine the treatment's safety and effectiveness. The trial consists of two parts: one to test different doses and another to identify the optimal dose. Individuals with this specific type of leukemia who have tried at least two other treatments without success may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications for the trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot have had cytotoxic treatment within 14 days, certain biologic treatments within 28 days, or medications that affect heart rhythm within 21 days. Check with the trial team for details on your specific medications.

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

Research has shown that AZD4512 is being tested for safety and tolerability in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). Although specific safety details from these studies are not yet available, the trial is in its early stages, with careful monitoring for any side effects.

Since the trial is just beginning, information on treatment tolerability is limited. Early-phase trials typically focus on determining a drug's safety and identifying safe doses. Prospective participants should understand that the trial aims to find the optimal dose and assess any potential side effects of AZD4512 in real-life situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute lymphoblastic leukemia?

Unlike the standard treatments for acute lymphoblastic leukemia (ALL) that typically involve chemotherapy or targeted therapy drugs like imatinib or dasatinib, AZD4512 targets both Philadelphia chromosome positive and negative B-ALL. This is exciting because AZD4512 works by a novel mechanism of action that might overcome resistance seen in some patients with existing treatments. Researchers are eager to see if AZD4512 could offer a new option for patients whose leukemia has relapsed or is resistant to current therapies, potentially providing a more effective and safer alternative.

What evidence suggests that AZD4512 might be an effective treatment for acute lymphoblastic leukemia?

Research shows that AZD4512 is under investigation as a potential treatment for relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL). The trial consists of two modules: Module 1 evaluates escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose, while Module 2 further explores these doses to optimize the treatment. This treatment targets specific proteins in cancer cells, potentially stopping cancer growth. Early results suggest AZD4512 could be effective due to its direct interaction with these cancer proteins. Although human research is ongoing, initial signs are promising, indicating AZD4512 might help manage the disease in some patients. Additional studies are underway to fully understand its potential benefits and safety. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with relapsed or refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL). Specific eligibility details are not provided, but typically participants must meet certain health criteria and have a history of the condition being studied.

Inclusion Criteria

My leukemia is either Ph(-) or Ph(+) and is resistant or has a minimal disease presence.

I have been diagnosed with B-cell Acute Lymphoblastic Leukemia.

The number of enrolled participants with MRD ≥ 1 to ≤ 5% will be limited to 25% of the DE cohort

Exclusion Criteria

I don't have ongoing major side effects from treatment, except for hair loss, stable nerve issues, skin color loss, or hormone issues that are under control.

I've had lung inflammation from medication that needed steroids or extra oxygen.

I haven't had certain cancer treatments or specific medications in the required time before joining this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) in participants with relapsed/refractory B-ALL.

6 months

Dose Optimization

Module 2 will randomize participants to receive AZD4512 monotherapy across 2 to 3 dose levels identified in Module 1 to identify the recommended Phase 2 dose (RP2D).

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD4512

Trial Overview The study focuses on AZD4512, either alone or combined with other cancer treatments. It aims to evaluate its safety, how well it's tolerated by patients, how the body processes it, and its effectiveness against r/r B-ALL.

How Is the Trial Designed?

Group I: Module 2 Dose Optimization Experimental Treatment 1 Intervention

Module 2 will randomize participants with R/R (as defined by NCCN guidelines) Ph(-) BALL only across 2 to 3 dose levels identified in Module 1 to receive AZD4512 monotherapy for further exploration of the doses. The aim of Module 2 is to identify the recommended Phase 2 dose (RP2D) of AZD4512 monotherapy, evaluate the efficacy and further define the safety profile of AZD4512.

Group II: Module 1 Dose Escalation Experimental Treatment 1 Intervention

Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in Module 2 (dose optimization), in participants with relapsed/refractory (R/R) Philadelphia chromosome positive (Ph\[+\]) and negative (Ph\[-\]) B-ALL, R/R as defined by National Comprehensive Cancer Network (NCCN) guidelines.

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

Fortrea

Industry Sponsor

Trials

22

Recruited

5,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07109219

NCT07109219 | Study of AZD4512 Monotherapy or in ... The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B- ...

2. withpower.com withpower.com/trial/phase-2-precursor-b-cell-lymphoblastic-leukemia-lymphoma-9-2025-a9916

AZD4512 for Acute Lymphoblastic Leukemia (ALLight Trial) The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B- ...

3. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-azd4512-monotherapy-or-combination-anticancer-agents-participants-trial-nct07109219

Study of AZD4512 Monotherapy or in Combination With ... This Interventional study is looking for people with B-cell Acute Lymphoblastic Leukemia (B-ALL) in Valencia Spain, Taipei Taiwan, Seoul South Korea to take ...

4. ctv.veeva.com ctv.veeva.com/study/study-of-azd4512-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-acute-lym

Study of AZD4512 Monotherapy or in Combination With ... The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/ ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04440267?term=AREA%5BConditionSearch%5D(%22Acute%20Leukemia%20of%20Ambiguous%20Lineage%22)&rank=2

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy ... Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ...

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D9891C00001/

Study of AZD4512 monotherapy or in combination with ... The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT07109219

Study of AZD4512 Monotherapy or in Combination With ... Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia ... Download Trial Data.

8. astrazeneca.com astrazeneca.com/our-therapy-areas/pipeline.html

Pipeline Our pipeline forms a robust portfolio of investigational therapies in varied stages of clinical development.