Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests AZD4512 alone or with other cancer drugs for B-cell acute lymphoblastic leukemia (B-ALL), a cancer of the blood and bone marrow. It is for people whose cancer came back or did not respond to treatment. Researchers will study side effects, how the body handles the drug, and how well it works.
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Meet the age rule for your study part: Module 1 lists age 16 (18 or older in the US); Module 2 lists age 12.
- Have B-ALL with a marker called CD22. The cancer must have come back or not responded to treatment.
- Module 1 dose testing allows cancer with or without the Philadelphia chromosome, a gene change. Extra Module 1 spots and Module 2 allow only cancer without this change.
- Meet the study’s scores for daily activity and ability to care for yourself.
- Have fewer than 10,000 immature leukemia cells per microliter of blood. Treatment to lower this count may be allowed before starting.
- For Module 1 dose testing, have cancer that came back or resisted at least 2 treatments, or 1 treatment if no standard options remain. Extra Module 1 spots and Module 2 require at least 1 prior treatment that failed.
- If you have the Philadelphia chromosome, meet added rules for targeted drugs called TKIs. Prior CD22-targeted treatment is allowed if your cancer was not resistant to it.
- Wait more than 4 weeks after a donor immune-cell infusion, 8 weeks after cell therapy or a stem cell transplant using your own cells, or 12 weeks after a donor stem cell transplant.
Who can't join
- Have Burkitt lymphoma or leukemia.
- Have cancer only outside the bone marrow, or active cancer in the testicles, brain, or spinal cord.
- Have ongoing moderate or worse side effects not related to blood counts. Exceptions include hair loss, stable mild or moderate nerve damage, loss of skin color, and hormone problems controlled with treatment.
- Have past drug-related lung inflammation that needed steroid pills, IV steroids, or extra oxygen, or possible lung inflammation that screening scans cannot rule out.
- Have had cell-killing cancer treatment within 14 days, except allowed ALL maintenance drugs or treatment to lower leukemia cell counts. Recent immune-based treatment also requires a waiting period.
- Have had radiation outside the brain or spinal cord within 2 weeks, or radiation to those areas within 4 weeks.
- Have recently taken certain drugs that affect heart rhythm or strongly block the liver enzyme CYP3A4, which helps break down drugs. Required waiting times depend on the drug.
- Have recently received an experimental drug or study treatment. The wait is at least 30 days, or longer for drugs that leave the body slowly; some B-ALL treatments have different waiting rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 1\. Age: * 16 years old in Module 1 (US only: ≥18year) * 12 years old in Module 2 2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022). * All Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB) * Module 1 (DE): R/R B-ALL \[Ph(-) and Ph(+)\] * Backfill of Module 1 and Module 2 (DO): R/R B-ALL \[Ph(-)\] with demonstration of CD22 expression by local assessment in screening. 3\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50) 4\. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria) 5\. Prior therapies: * Module 1 (DE): At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. For Ph+ B-ALL: intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI * Backfill of Module 1 (backfills) and Module 2 (DO): at least one prior line of therapy (SOC or clinical trial) to which the participant has been either refractory or has subsequently relapsed. * Participants who have received prior CD22 targeted therapies and were not refractory to these therapies are eligible 6\. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks Exclusion Criteria: 1. Burkitt lymphoma and leukemia 2. Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement 3. Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy) 4. History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening 5. Prior/concomitant therapy * Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction) * Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter) * Non-CNS radiation within 2 weeks \& CNS radiation within 4 weeks * Medications known to prolong QTc and/or associated with Torsades de Pointes within 5 half-lives * Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer) * Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer. If the investigational product is an agent to treat B-ALL and meets the modality criteria, then a specific washout period must be adhered to instead.
Study sites (6)
CA
- Research Site · Duarte, CA 91010More trials in Duarte
FL
- Research Site · Jacksonville, FL 32224More trials in Jacksonville
IA
- Research Site · Iowa City, IA 52242More trials in Iowa City
IL
- Research Site · Chicago, IL 60611More trials in Chicago
TN
- Research Site · Franklin, TN 37067More trials in Franklin
TX
- Research Site · Houston, TX 77030More trials in Houston