Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed for relapsed/refractory peripheral T-cell lymphoma and relapsed or refractory haematological malignancies, including advanced blood cancers. It is being studied in patients with conditions such as acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, and multiple myeloma.
AZD4573 is a small molecule designed to inhibit CDK2, a cyclin-dependent kinase involved in cell cycle regulation. By targeting CDK2, AZD4573 aims to disrupt cancer cell proliferation in haematological malignancies.
AZD4573 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of AZD4573 in patients with blood cancers.
AZD4573 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and antitumor activity in patients with relapsed or refractory haematological malignancies.
AZD4573 has been studied in several clinical trials, including NCT03263637, which assessed its safety and antitumor activity in relapsed/refractory haematological malignancies, and NCT04630756, which evaluated it in combination with other anti-cancer agents. These trials have been completed.
AZD4573 is a distinct investigational compound developed by AstraZeneca. It is not known to be the same as any other marketed drug. Its unique mechanism of targeting CDK2 differentiates it from other cancer therapies.