Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-11
83
Participants Needed
26
Research Sites
9 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying AZD4512 in adults and young adults with relapsed or refractory B-Cell acute lymphoblastic leukemia (B-ALL). This Phase I/II, open-label, multi-center trial aims to assess the safety, tolerability, how the body processes the drug, and its effects on this type of leukemia. The study includes both Philadelphia chromosome positive and negative B-ALL patients, with a focus on finding the best dose and evaluating the drug's impact on the disease. The trial has two parts: Module 1 evaluates increasing doses of AZD4512 given as monotherapy through intravenous infusion to find the maximum tolerated dose and doses for further study. Module 2 randomizes participants with Philadelphia chromosome negative B-ALL to receive different dose levels identified in Module 1 to optimize dosing, assess efficacy, and further evaluate safety. AZD4512 is an antibody-drug conjugate targeting CD22, a protein found on leukemia cells. Participants will be monitored for dose-limiting toxicities, treatment-related side effects, laboratory changes, ECGs, and vital signs during and after treatment. Researchers will measure overall response rates, complete remission rates, survival outcomes, and pharmacokinetic parameters over periods ranging from weeks to up to 38 months. Safety follow-up continues for about six months after the last dose. This comprehensive monitoring helps determine the recommended dose and assess the drug's effects and safety profile.
CONDITIONS
Brief Title
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older for Module 1 (US only: 18 years or older); age 12 years or older for Module 2
- Known diagnosis of CD22-positive B-Cell acute lymphoblastic leukemia (B-ALL) as defined by WHO criteria
- Relapsed or refractory B-ALL, with bone marrow blasts greater than 5% or reappearance of blasts in peripheral blood
- Module 1 includes both Philadelphia chromosome positive and negative relapsed/refractory B-ALL; Module 2 includes relapsed/refractory Philadelphia chromosome negative B-ALL
- Performance status: ECOG 2 or less; Karnofsky Performance Status 50 or above; Lansky Performance Status 50 or above
- Peripheral lymphoblast count less than 10,000/µL (cytoreduction allowed before first dose)
- At least two prior therapies with relapse or refractory disease, or one prior therapy with relapse or refractory disease with no standard options available
- Prior donor lymphocyte infusion more than 4 weeks ago, prior cell therapy or autologous stem cell transplant more than 8 weeks ago, allogeneic stem cell transplant more than 12 weeks ago
- For Philadelphia chromosome positive B-ALL (Module 1 only): intolerant to or contraindicated for tyrosine kinase inhibitor therapy or relapsed/refractory despite treatment with at least two prior TKIs or one third-generation TKI
You will not qualify if you...
- Diagnosis of Burkitt lymphoma and leukemia
- Isolated extramedullary disease or active testicular or central nervous system involvement beyond CNS1
- Unresolved non-blood related toxicities Grade 2 or higher, except for alopecia, stable Grade 2 or less neuropathy, vitiligo, or controlled endocrine disorders
- History of drug-induced non-infectious interstitial lung disease or pneumonitis requiring steroids or oxygen, or suspected lung disease not ruled out by imaging
- Recent treatments including cytotoxic therapy within 14 days (except maintenance or cytoreduction), immuno-oncology treatment within 28 days or five half-lives, recent non-CNS radiation within 2 weeks or CNS radiation within 4 weeks
- Use of medications known to prolong QTc or cause Torsades de Pointes within five half-lives
- Use of strong CYP 3A4 inhibitors within 14 days or five half-lives
- Participation in investigational drug studies within 30 days or five half-lives prior to first dose unless specific washout period applies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months on average during dosing period
Participants receive AZD4512 monotherapy via intravenous infusion to evaluate safety, tolerability, and efficacy in relapsed or refractory B-Cell acute lymphoblastic leukemia.
Visits occur regularly during dosing; exact number depends on treatment schedule
Duration - Up to 38 months post first dose
Participants are monitored for safety, response, and long-term outcomes after completing treatment with AZD4512.
Periodic visits for assessments during follow-up period
Trial Site Locations
Total: 26 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
Jacksonville, Florida, United States, 32224
Withdrawn
3
Research Site
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Research Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Research Site
Franklin, Tennessee, United States, 37067
Actively Recruiting
6
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
7
Research Site
Melbourne, Australia, 3000
Actively Recruiting
8
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Not Yet Recruiting
9
Research Site
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
10
Research Site
Guangzhou, China, 510515
Not Yet Recruiting
11
Research Site
Tianjin, China, 301600
Not Yet Recruiting
12
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
13
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
14
Research Site
Seoul, South Korea, 03080
Actively Recruiting
15
Research Site
Seoul, South Korea, 06351
Actively Recruiting
16
Research Site
Seoul, South Korea, 06591
Actively Recruiting
17
Research Site
Seoul, South Korea, 3722
Actively Recruiting
18
Research Site
Badalona(Barcelona), Spain, 08916
Not Yet Recruiting
19
Research Site
Barcelona, Spain, 08035
Actively Recruiting
20
Research Site
Salamanca, Spain, 37007
Actively Recruiting
21
Research Site
Santander, Spain, 39008
Actively Recruiting
22
Research Site
Valencia, Spain, 46026
Withdrawn
23
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
24
Research Site
Taipei, Taiwan, 106
Actively Recruiting
25
Research Site
Bloomsbury, United Kingdom, W1T 7HA
Actively Recruiting
26
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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