Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5153 · 1 trial · 6 indications
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 |
|---|---|---|
| AZD5153 Monotherapy | EXPERIMENTAL | Patients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine maximum tolerated dose (MTD). AZD5153 will be taken once per day (QD) or two times per day (BID) for 21 days as an oral capsule. Once the MTD is finalized, patients may be enrolled into an expansion cohort at the MTD. |
| AZD5153 + Olaparib Combination Therapy | EXPERIMENTAL | Patients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine MTD. AZD5153 will be taken as oral capsules BID in combination with 300 mg olaparib BID for 21 days. |
| Name | Type | Description |
|---|---|---|
| AZD5153 | DRUG | AZD5153 is to be taken as oral capsules once or twice per day each day in 21 day cycles. Dosing will continue until disease progression or other study discontinuation criteria are met. |
| Olaparib | DRUG | Olaparib, 300 mg, will be taken BID as oral capsules. |
Inclusion Criteria for all Patients: 1. Patient must be able to understand the nature of the study and provide a signed and dated, written informed consent prior to any study specific procedures, sampling or analyses. 2. Patients should have the ability and willingness to comply with the study and ...
AZD5153 is an investigational small molecule being studied for the treatment of malignant solid tumors, including lymphomas, ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It is being developed by AstraZeneca PLC as an oncology therapy and has been evaluated in a Phase 1 clinical trial in patients with relapsed or refractory solid tumors.
AZD5153 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating AZD5153 in patients with relapsed or refractory solid tumors, including lymphomas.
AZD5153 is in Phase 1 clinical development. It has been evaluated in a single Phase 1 trial that is now completed, with no active trials currently listed. The trial enrolled 49 patients and was conducted in the United States and Canada.
AZD5153 has been studied in one Phase 1 clinical trial, NCT03205176, titled "AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas." The trial enrolled 49 patients, was controlled, was not randomized or double-blind, and is now completed. It included patients with solid tumors, lymphoma, ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.
Yes, the AZD5153 Phase 1 trial NCT03205176 was biomarker-selected, meaning enrollment was guided by specific biomarker criteria. The study enrolled 49 adult patients aged 18 years and older of all sexes with relapsed or refractory solid tumors, including lymphomas, and did not include healthy volunteers.