Actively Recruiting
A Modular Phase I/II Open-label, Multicenter Study to Evaluate AZD4512 Alone or With Other Anticancer Agents in Adults With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Led by AstraZeneca · Updated on 2026-05-08
91
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD4512, an antibody-drug conjugate, alone or combined with other anticancer agents in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL) who have already received at least two prior therapies. This Phase I/II open-label, global, multicenter study aims to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and effectiveness of AZD4512 across various B-NHL subtypes. The study is sponsored by AstraZeneca and includes different modules for specific B-NHL subtypes. Participants receive AZD4512 administered by intravenous infusion in Module 1, which consists of dose escalation and pharmacodynamic/safety backfill phases to determine the maximum tolerated dose and optimal biological dose. Future modules may study AZD4512 alone or combined with other anticancer agents in particular B-NHL subtypes. The study does not use randomization or blinding. During the study, participants are monitored for dose-limiting toxicities, treatment-emergent and treatment-related adverse events, serious adverse events, and laboratory and vital sign changes from the first dose until 30 days after the last dose. Longer-term measurements include response rates, duration of response, survival, and various pharmacokinetic parameters up to two years. Safety and efficacy are closely followed throughout the treatment and observation periods.
CONDITIONS
Brief Title
A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Documented diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per WHO 2021 classification
- Relapsed or refractory disease after at least two prior lines of therapy
- For large B-cell lymphomas, must have progressed after anti-CD20 and chemotherapy and be ineligible or considered for CAR-T, T cell engager, or stem cell transplant
- Mantle cell lymphoma patients must have received anti-CD20 and BTK inhibitor
- Follicular lymphoma patients must have failed anti-CD20 with active disease requiring therapy
- Measurable disease by Lugano 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ and bone marrow function as specified
You will not qualify if you...
- Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or CLL/SLL
- Active central nervous system involvement from B-NHL
- Receipt of CAR-T or T cell engager therapies within 90 days prior to first treatment dose
- Use of investigational drugs or systemic anticancer therapies within 21 days or 5 half-lives prior to treatment
- Curative radiation within 14 days prior to treatment (localized palliative radiotherapy allowed)
- Allogeneic hematopoietic stem cell transplantation within 180 days unless stable without active graft-versus-host disease for at least 2 months
- Autologous hematopoietic stem cell transplantation within 90 days unless resolved toxicities
- Major surgery within 28 days prior to treatment
- Use of strong CYP3A4 inhibitors or QT interval-prolonging agents at treatment start
- Other malignancies within 2 years prior to treatment
- Unresolved grade 2 or higher adverse events from prior therapy except specified tolerable conditions
- Serious uncontrolled medical conditions or active infections within 14 days
- History or suspicion of significant interstitial lung disease or pneumonitis
- Pregnant or breastfeeding females
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 4 weeks or until discontinuation
Participants receive AZD4512 monotherapy or in combination with other anticancer agents to evaluate safety and efficacy.
Multiple visits during treatment depending on dosing schedule
Duration - Up to 2 years
Participants are monitored for treatment-emergent adverse events and long-term outcomes after completing treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 22 locations
1
Research Site
Irvine, California, United States, 92618
Actively Recruiting
2
Research Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Research Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Research Site
New York, New York, United States, 10016
Actively Recruiting
5
Research Site
New York, New York, United States, 10021
Actively Recruiting
6
Research Site
Cleveland, Ohio, United States, 44195
Withdrawn
7
Research Site
Myrtle Beach, South Carolina, United States, 29572
Withdrawn
8
Research Site
Franklin, Tennessee, United States, 37067
Actively Recruiting
9
Research Site
Melbourne, Australia, 3000
Actively Recruiting
10
Research Site
Chengdu, China, 610041
Not Yet Recruiting
11
Research Site
Guangzhou, China, 510060
Not Yet Recruiting
12
Research Site
Bologna, Italy, 40138
Actively Recruiting
13
Research Site
Milan, Italy, 20133
Actively Recruiting
14
Research Site
Milan, Italy, 20141
Actively Recruiting
15
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
16
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
17
Research Site
Seoul, South Korea, 03080
Actively Recruiting
18
Research Site
Seoul, South Korea, 5505
Actively Recruiting
19
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
20
Research Site
Taipei, Taiwan, 106
Actively Recruiting
21
Research Site
London, United Kingdom, W1T 7HA
Actively Recruiting
22
Research Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
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
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here