Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-AZD5305 (therapeutic dose)
AZD5305 · 3 trials · 15 indications
The effect of Itraconazole on the AUCinf of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite\[s\], if applicable) relative to reference intervention (AZD5305 alone) of AUCinf will be presented.
The effect of Itraconazole on the AUClast of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite\[s\], if applicable) relative to reference intervention (AZD5305 alone) of AUClast will be presented.
The effect of Itraconazole on the Cmax of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite\[s\], if applicable) relative to reference intervention (AZD5305 alone) of Cmax will be presented.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline will be assessed.
To assess the safety and tolerability of AZD5305 when given in combination with NHA.
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
A DLT is defined as any toxicity that occurs from the first dose of study treatment (either AZD5305 or combination anti-cancer agent) up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. DLTs occurring outside the DLT window (ie, late onset toxicities) may be defined as a DLT after consultation with the sponsor and investigators, based on the emerging safety profile.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Part A: The participants will receive a single oral dose of AZD5305 on Day 1, followed by a 2-day washout. Then Itraconazole will be dosed for 3 days \[BD\] on Day 4 and \[OD\] on Days 5 and 6, then a single oral dose of AZD5305 administered concurrently with Itraconazole on Day 7 and only Itraconazole on Days 8 to 12. Part B: Patients proceeding to Part B after completing Part A of the study will receive AZD5305 OD as monotherapy. |
| Arm 1 (AZD5305 in combination with enzalutamide) | EXPERIMENTAL | Patients will receive an oral dose of AZD5305 and Enzalutamide once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur. |
| Arm 2 (AZD5305 in combination with abiraterone acetate) | EXPERIMENTAL | Patients will receive an oral dose of AZD5305 and Abiraterone Acetate once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur. |
| Arm 3 (AZD5305 in combination with darolutamide) | EXPERIMENTAL | Patients will receive an oral dose of AZD5305 once daily and Darolutamide twice daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur. |
| Arm 4 (AZD5305 in combination with apalutamide) | EXPERIMENTAL | Patients will receive an oral dose of AZD5305 and Apalutamide once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur. |
| Module 1: AZD5305 Monotherapy | EXPERIMENTAL | AZD5305 Monotherapy |
| Module 2: AZD5305 + Paclitaxel | EXPERIMENTAL | AZD5305 + Paclitaxel |
| Module 3: AZD5305 + Carboplatin with or without Paclitaxel | EXPERIMENTAL | AZD5305 + Carboplatin with or without Paclitaxel |
| Module 4: AZD5305 + Trastuzumab Deruxtecan | EXPERIMENTAL | AZD5305 + T- DXd |
| Module 5 AZD5305 + Datopotamab Deruxtecan | EXPERIMENTAL | AZD5305 + Dato-DXd |
| Module 6 AZD5305 + Camizestrant | EXPERIMENTAL | AZD5305 + Camizestrant |
| Name | Type | Description |
|---|---|---|
| AZD5305 | DRUG | In Part A, the participants will receive a single dose of AZD5305 on Day 1 and Day 7. In Part B, the participants will receive AZD5305 once daily. |
| Itraconazole | DRUG | In Part A, the participants will receive Itraconazole twice daily on Day 4 and once daily on Days 5-12 |
| Enzalutamide | DRUG | Patients will receive an oral dose of Enzalutamide once daily |
| Abiraterone Acetate | DRUG | Patients will receive an oral dose of Abiraterone Acetate once daily |
| Darolutamide | DRUG | Patients will receive an oral dose of Darolutamide twice daily |
| Apalutamide | DRUG | Patients will receive an oral dose of Apalutamide once daily |
| Paclitaxel | DRUG | IV Anti-microtubule agent |
| Carboplatin | DRUG | IV Platinum chemotherapeutic |
| T- Dxd | DRUG | IV Antibody-drug conjugate |
| Dato-DXd | DRUG | IV Antibody-drug conjugate |
| Camizestrant | DRUG | Oral SERD Molecule |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. * Males and females aged ≥ 18 years at the time of screening. * Patients with documented evidence of locally advanced unresectable or metastatic solid tumours...
AZD5305 is an investigational small molecule being studied for the treatment of advanced solid malignancies, ovarian cancer, and metastatic prostate cancer. It is being evaluated in clinical trials for these oncology indications.
AZD5305 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various advanced cancers.
AZD5305 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are designed to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
AZD5305 is being studied in three Phase 1 trials: NCT04644068, a monotherapy and combination study in advanced solid malignancies with 702 participants; NCT05367440, a combination study with new hormonal agents in metastatic prostate cancer with 174 participants; and NCT05573724, a drug-drug interaction study with itraconazole in advanced solid malignancies, which has been completed.
AZD5305 is also known as [14C]-AZD5305 when administered at a therapeutic dose. The radiolabeled form is used in clinical studies to track the drug's absorption, distribution, metabolism, and excretion in the body.