In short
Clinical trials are studying AZD4512 in people with B-cell blood cancers. These studies aim to learn about safety, tolerability, and how well AZD4512 may work in non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia. The trials include adults with relapsed or refractory disease, meaning the cancer came back or did not respond well to past treatment.
Key points
- Clinical trials of AZD4512 are being done in people with B-cell blood cancers, including B-cell non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia. Both studies are Phase 1/2, so they first focus on safety, tolerability, and dose finding. The lymphoma trial includes people with relapsed or refractory disease, while the leukemia trial includes relapsed or refractory B-ALL. The leukemia study has a dose escalation part and a dose optimization part, which helps researchers choose the best dose to study further. Main results include side effects, serious side effects, dose-limiting toxicities, and early signs of cancer response. The trials are authorised and use AZD4512 as an IV infusion.
Trials overview
Two authorised interventional studies are investigating AZD4512 in people with B-cell blood cancers. Both studies are Phase 1/2 trials, which means they first look at safety and dose, and then also look for early signs that the treatment may help.
AZD4512 study in B-cell non-Hodgkin lymphoma
The first trial is studying AZD4512 in people with B-cell non-Hodgkin lymphoma (B-NHL). Its title says the researchers want to learn how safe AZD4512 is, both with and without other cancer drugs, and how it works in the bodies of people with B-NHL.
The brief summary says the main goal is to assess the safety and tolerability of AZD4512 used by itself in participants with relapsed or refractory B-NHL, and to establish the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD). Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.
This study plans to enroll 99 people. The treatment is AZD4512 given as an IV infusion, which means it is delivered through a vein.
AZD4512 study in B-cell acute lymphoblastic leukemia
The second trial is studying AZD4512 in people with B-cell acute lymphoblastic leukemia (B-ALL). Its title says the researchers want to learn how safe AZD4512 is and how it works in the bodies of people with B-ALL.
This study has two parts, called Module 1 Dose Escalation and Module 2 Dose Optimization. In Module 1, the trial includes people with relapsed or refractory B-ALL, both Ph(-) and Ph(+), according to NCCN guidelines. In Module 2, the trial focuses on relapsed or refractory Ph(-) B-ALL and looks more closely at how well AZD4512 may work.
The study plans to enroll 83 people and also uses AZD4512 as an IV infusion. In the dose optimization part, the researchers aim to determine the recommended phase 2 dose (RP2D), which is the dose chosen for later studies after safety and early results are reviewed.
What the trials measure
Both trials focus on safety first. The lymphoma study measures the percentage of participants with dose-limiting toxicities (DLT), the frequency, duration, and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs), plus side effects that lead to stopping treatment, and clinically important changes in vital signs and laboratory tests.
The leukemia study measures similar safety items, including DLTs, TEAEs, TRAEs, SAEs, treatment interruptions, dose changes, delays, discontinuations, and clinically important changes from baseline, which means changes from the first measurement taken before treatment started.
The leukemia study also measures antitumour activity, which means early signs that the treatment may reduce the cancer. Its main response measure is objective response rate (ORR), including complete response (CR) and complete response with partial hematologic recovery (CRh).
Who may be able to join
Based on the trial data, the studies are for people with B-cell blood cancers that have come back or have not responded well to earlier treatment. The lymphoma study is for participants with relapsed or refractory B-NHL, and the leukemia study is for participants with relapsed or refractory B-ALL.
The leukemia trial has a broader group in the first module because it includes both Ph(-) and Ph(+) B-ALL, while the second module focuses on Ph(-) B-ALL only. Ph(-) and Ph(+) are labels used in leukemia to describe whether a specific chromosome change is present or not.
Trial phases and what they mean
Both studies are in Phase 1/2, which is common for early cancer research. Phase 1 parts are mainly about safety, side effects, and finding the right dose, while Phase 2 parts look more closely at whether the treatment may help the cancer.
In the leukemia study, the dose escalation part is used to find the MTD and doses to explore later, and the dose optimization part is used to help choose the RP2D and assess early efficacy. In the lymphoma study, the researchers aim to find the MTD and/or OBD while studying safety and tolerability.