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AZD5335 · 2 trials · 4 indications
PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.
The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed.
The effect of itraconazole on the PK of AZ14170132 will be assessed.
| Arm | Type | Description |
|---|---|---|
| AZD5335 in FRa-high cohort | EXPERIMENTAL | AZD5335 IV (intravenous) in FRa-high cohort |
| Mirvetuximab Soravtansine (MIRV) in FRa-high cohort | ACTIVE_COMPARATOR | MIRV AIBW IV in FRa-high cohort |
| AZD5335 in FRa-low cohort | EXPERIMENTAL | AZD5335 IV (intravenous) in FRa-low cohort |
| Investigator´s choice chemotherapy in FRa-low cohort | ACTIVE_COMPARATOR | Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor |
| AZD5335/AZD5335 + Itraconazole | EXPERIMENTAL | In Part A, participants will receive AZD5335 alone as an intravenous (IV) infusion, and in combination with oral itraconazole, every 3 weeks (Q3W) from cycle 1 to cycle 3. In Part B, participants will receive AZD5335 as an IV infusion Q3W, from Day 1 of Cycle 4 until progression, unacceptable toxicity or any other specified criteria for discontinuation occurs. |
| Name | Type | Description |
|---|---|---|
| AZD5335 | DRUG | antibody drug conjugate |
| Mirvetuximab Soravtansine (MIRV) | DRUG | antibody drug conjugate |
| Paclitaxel | DRUG | chemotherapy |
| Pegylated liposomal Doxorubicin (PLD) | DRUG | chemotherapy |
| Topotecan | DRUG | chemotherapy |
| Itraconazole | DRUG | Itraconazole capsule will be administered orally. |
Key Inclusion criteria * Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer. * Participants must have platinum-resistant disease: * Participants who have only had one prior line of platinum-based therapy must have received at least 4 ...
AZD5335 is an investigational small molecule being developed for the treatment of epithelial ovarian cancer and fallopian tube cancer. It is currently being studied in a Phase 3 clinical trial for platinum-resistant ovarian cancer, specifically in patients whose tumors are classified as FRα-high or FRα-low.
AZD5335 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company is currently conducting clinical trials to evaluate the drug's safety and efficacy in patients with ovarian and fallopian tube cancers.
AZD5335 is currently in Phase 3 clinical development. The most advanced trial, NCT07218809, is a Phase 3 study comparing AZD5335 against mirvetuximab soravtansine in FRα-high patients and against chemotherapy in FRα-low patients with platinum-resistant ovarian cancer. The trial is actively recruiting participants.
AZD5335 is being evaluated in two clinical trials. The first is NCT07218809, a Phase 3 study with an enrollment of 1,100 participants comparing AZD5335 to mirvetuximab soravtansine or chemotherapy in platinum-resistant ovarian cancer. The second is NCT07402915, a Phase 1 drug-drug interaction study with itraconazole in patients with ovarian, primary peritoneal, or fallopian tube cancer.
No, AZD5335 is not the same as mirvetuximab soravtansine. AZD5335 is a small molecule being developed by AstraZeneca, while mirvetuximab soravtansine is an antibody-drug conjugate used as a comparator in the Phase 3 trial NCT07218809. The study is designed to compare the two treatments in patients with FRα-high platinum-resistant ovarian cancer.