Multiple clinical trials evaluate AZD4573 across Phase 1, Phase 1/2, and Phase 2 studies, primarily targeting relapsed or refractory haematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, peripheral T-cell lymphoma, classical Hodgkin lymphoma, and multiple myeloma. Industry sponsors, including AstraZeneca and Parexel, spearhead these evaluations assessing AZD4573 both as a monotherapy and in combination regimens. Encompassing completed as well as active, non-recruiting studies, these trials yield critical safety, tolerability, and preliminary efficacy data for hematologic oncology.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04630756 | COMPLETED | Advanced Haematological Malignancies |
AstraZeneca |
2021-02-17 | PHASE1; PHASE2 |
| NCT05140382 | COMPLETED | Relapsed/Refractory Peripheral T-cell Lymphoma; Relapsed/Refractory Classical Hodgkins Lymphoma |
AstraZeneca |
2021-12-15 | PHASE2 |
| NCT05140382 | Completed | Relapsed/Refractory Peripheral T-cell Lymphoma|Relapsed/Refractory Classical Hodgkins Lymphoma |
AstraZeneca |
2021-12-15 | Phase 2 |
| NCT03263637 | COMPLETED | 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 Non-Hodgkin Lymphoma; T-cell Non-Hodgkin Lymphoma; Small Lymphocytic Lymphoma; Multiple Myeloma |
AstraZeneca |
2017-10-24 | PHASE1 |
| NCT04630756 | Active not recruiting | Advanced Haematological Malignancies |
AstraZeneca|Parexel |
2021-02-17 | Phase 1|Phase 2 |
| NCT03263637 | Completed | 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 Non-Hodgkin Lymphoma|T-cell Non-Hodgkin Lymphoma|Small Lymphocytic Lymphoma|Multiple Myeloma |
AstraZeneca |
2017-10-24 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2025-04-09)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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