Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZ14170132, Torvutatug samrotecan, Torvu-sam
AZD5335 · 5 trials · 10 indications
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.
PFS is defined as the time from randomization to radiographic progression as assessed by BICR 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.
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination.
A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol)
| Arm | Type | Description |
|---|---|---|
| Torvutatug samrotecan monotherapy or in combination with bevacizumab | EXPERIMENTAL | Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV. |
| Observation or bevacizumab | ACTIVE_COMPARATOR | Observation or bevacizumab IV. |
| Torvutatug samrotecan + Bevacizumab | EXPERIMENTAL | Torvutatug samrotecan IV (intravenous) + Bevacizumab IV |
| Bevacizumab | ACTIVE_COMPARATOR | Bevacizumab IV |
| 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. |
| Module 1: Torvu-sam Monotherapy | EXPERIMENTAL | Torvu-sam Monotherapy |
| Module 2: Torvu-sam + Saruparib | EXPERIMENTAL | Torvu-sam + Saruparib |
| Module 3: Torvu-sam + Bevacizumab | EXPERIMENTAL | Torvu-sam + Bevacizumab |
| Module 4: Torvu-sam + Carboplatin +/- Bevacizumab | EXPERIMENTAL | Torvu-sam + Carboplatin +/- Bevacizumab |
| Module 5: Torvu-sam + Palacaparib +/- Bevacizumab | EXPERIMENTAL | Torvu-sam + Palacaparib +/- Bevacizumab |
| Module 6: Torvu-sam + Pembrolizumab +/- Palacaparib | EXPERIMENTAL | Torvu-sam + Pembrolizumab +/- Palacaparib |
| Name | Type | Description |
|---|---|---|
| Torvutatug samrotecan | DRUG | FRa targeting antibody drug conjugate Topoisomerase I inhibitor |
| Bevacizumab | DRUG | Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor |
| 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. |
| Saruparib | DRUG | Oral PARP inhibitor |
| Carboplatin | DRUG | IV Alkylating agent |
| Palacaparib | DRUG | Oral PARP inhibitor |
| Pembrolizumab | DRUG | IV Biologic |
Inclusion Criteria: * Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. * Provision of an archival FFPE tumour sample * Participants who received at least one, and no more than 2 lines of prior systemic antic...
AZD5335 is being developed for the treatment of epithelial ovarian cancer and fallopian tube cancer. It is also being studied in primary peritoneal cancer. The Phase 3 trial evaluates AZD5335 in platinum-resistant ovarian cancer, comparing it with mirvetuximab soravtansine in FRα-high patients and with chemotherapy in FRα-low patients.
AZD5335 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating AZD5335 in ovarian, fallopian tube, and primary peritoneal cancers.
AZD5335 is in Phase 3 clinical development. The Phase 3 trial NCT07218809 is currently recruiting participants with platinum-resistant ovarian cancer. A separate Phase 1 drug-drug interaction study, NCT07402915, is also recruiting.
AZD5335 is being evaluated in two recruiting clinical trials. NCT07218809 is a Phase 3 study comparing AZD5335 with mirvetuximab soravtansine in FRα-high and with chemotherapy in FRα-low platinum-resistant ovarian cancer, enrolling 1,100 participants. NCT07402915 is a Phase 1 drug-drug interaction study with itraconazole in ovarian, primary peritoneal, or fallopian tube cancer, enrolling 32 participants.
Yes, AZD5335 trials are biomarker-selected. The Phase 3 trial NCT07218809 stratifies patients by folate receptor alpha (FRα) expression, comparing AZD5335 with mirvetuximab soravtansine in FRα-high patients and with chemotherapy in FRα-low patients.