Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZ13810325
AZD4573 · 3 trials · 14 indications
Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.
Safety and tolerability of AZD4573 in combination with acalabrutinib was assessed.
Assessed safety and confirmed the RP2D of AZD4573 monotherapy in MCL participants and assessed the safety and tolerability of AZD4573 in combination with acalabrutinib in participants administered AZD4573 monotherapy.
Overall response rate (ORR), defined as the proportion of participants who have a tumour response (complete response \[CR\] and partial response \[PR\]).
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
DLTs will be determined from monitoring adverse events (AEs), and abnormal laboratory tests (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs (blood pressure and pulse), and electrocardiogram (ECG).
| Arm | Type | Description |
|---|---|---|
| AZD4573 (Monotherapy) | EXPERIMENTAL | Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy. |
| Module 1: Part A and Part B | EXPERIMENTAL | Participants will receive intravenous ascending doses of AZD4573 once weekly with oral acalabrutinib twice daily continuously in Part A. For Part A, cohorts 1, 2, and 3 have different target dose levels respectively. In Part B, participants will receive the RP2D of AZD4573 from Part A. |
| Module 2: Part A and Part B | EXPERIMENTAL | Participants will receive AZD4573 as monotherapy for Period 1 and AZD4573 + acalabrutinib as combination therapy for Period 2. Part B of Module 2 will be determined from the data emerging from Part A. |
| Arm A: (Cohort 1-3) | EXPERIMENTAL | dose level 1-3 in subjects with relapsed or refractory haematological malignancies excluding AML/ALL/high-risk MDS/CMML/CLL. |
| Arm B: (Cohort 1-3) | EXPERIMENTAL | dose level 1-3 in subjects with relapsed or refractory AML, ALL, high-risk MDS, CMML, CLL and Richter's syndrome. |
| Name | Type | Description |
|---|---|---|
| AZD4573 | DRUG | AZD4573 will be given intravenously |
| Acalabrutinib | DRUG | Oral Acalabrutinib capsule will be administered twice daily continuously from Day 1 of Cycle 1 Week 1 in combination with AZD4573. |
Inclusion Criteria: * Participants who are diagnosed with one of the following, as defined by the World Health Organisation: * Peripheral T-cell Lymphoma * Classical Hodgkin Lymphoma * Eastern Cooperative Oncology Group performance status of ≤ 2. * Must have received at least 1 prior line of t...
AZD4573 is an investigational small molecule being studied for the treatment of relapsed or refractory haematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, high risk myelodysplastic syndrome, chronic myelomonocytic leukemia, Richter's syndrome, B-cell and T-cell non-Hodgkin lymphoma, small lymphocytic lymphoma, multiple myeloma, and relapsed/refractory peripheral T-cell lymphoma.
AZD4573 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.
AZD4573 is in clinical development. It has completed Phase 1 and Phase 2 trials, but it is not approved by the FDA and remains investigational. The most advanced completed trial was a Phase 2 study in relapsed/refractory peripheral T-cell lymphoma and classical Hodgkin lymphoma.
AZD4573 has been studied in three completed clinical trials: NCT03263637, a Phase 1 study in relapsed/refractory haematological malignancies; NCT04630756, a Phase 1 study in advanced haematological malignancies; and NCT05140382, a Phase 2 study in relapsed/refractory peripheral T-cell lymphoma and classical Hodgkin lymphoma.
AZD4573 is a small molecule designed to target and inhibit CDK9, a cyclin-dependent kinase involved in transcriptional regulation. By inhibiting CDK9, it aims to reduce the expression of genes that promote cancer cell survival and proliferation, potentially leading to antitumor activity in haematological malignancies.
AZD4573 is the primary name for this investigational compound. No alternative names have been reported in the clinical trial data, so it is not known to be the same as any other marketed drug.