Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8701 · 1 trial · 9 indications
Determined according to Incidence and treatment related AEs and SAEs
Determined according to Incidence of DLTs (during the first 28 day cycle)
Determined according to Incidence of abnormal vital signs and laboratory parameters
Safety and tolerability of the MTD/OBD/MFD assessed through incidence of AEs and SAEs
The proportion of subjects achieving a confirmed complete or partial response according to RECIST 1.1 by investigator assessment
| Arm | Type | Description |
|---|---|---|
| Monotherapy | EXPERIMENTAL | Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years. |
| Combination Therapy | EXPERIMENTAL | Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years. |
| Name | Type | Description |
|---|---|---|
| AZD8701 | DRUG | FOXP3 antisense oligonucleotide |
| Durvalumab | BIOLOGICAL | anti PDL-1 monoclonal antibody |
Inclusion Criteria: The study is comprised of 2 main parts Monotherapy (AZD8701) and Combined Therapy (AZD8701 and Durvalumab). Inclusion criteria Dose escalation stages: * Histological or cytological confirmation of a solid, malignant tumour including HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal ...
AZD8701 is being studied for the treatment of clear cell renal cell cancer, a form of kidney cancer. It is also being evaluated in a range of other advanced solid tumors, including non-small-cell lung cancer, triple negative breast cancer, squamous cell cancer of the head and neck, small cell lung cancer, gastroesophageal cancer, melanoma, and cervical cancer.
AZD8701 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the compound in advanced solid tumors, including clear cell renal cell cancer.
AZD8701 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The Phase 1 program has completed, and the drug was studied in a first-time-in-human trial that enrolled 60 participants.
AZD8701 has been evaluated in one clinical trial, NCT04504669, titled a first-time-in-human study of AZD8701 with or without durvalumab in participants with advanced solid tumors. That Phase 1 trial is completed and enrolled 60 participants across the United States, Canada, France, and Spain.
The AZD8701 Phase 1 trial, NCT04504669, was a controlled study but was not randomized and not double blinded. It enrolled 60 participants aged 18 years and older, included both sexes, did not use healthy volunteers, and selected participants based on a biomarker.
The AZD8701 trial enrolled participants with advanced solid tumors, including clear cell renal cell cancer, non-small-cell lung cancer, triple negative breast neoplasms, squamous cell cancer of the head and neck, small cell lung cancer, gastroesophageal cancer, melanoma, and cervical cancer. The study was conducted in the United States, Canada, France, and Spain.