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AZD8701

Phase 1

Clear Cell Renal Cell Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Nov 5, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

AZD8701 · 1 trial · 9 indications

Phase 1 1
NCT04504669First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid TumoursClear Cell Renal Cell Cancer
COMPLETED60 Analytics
PHASE1COMPLETED
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours
Clear Cell Renal Cell CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs
From screening until 105 days after last dose of study treatment

Determined according to Incidence and treatment related AEs and SAEs

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of Dose Limiting Toxicities (DLTs)
First 28 day cycle

Determined according to Incidence of DLTs (during the first 28 day cycle)

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of vital signs and abnormal laboratory parameters
From screening until 105 days after last dose of study treatment

Determined according to Incidence of abnormal vital signs and laboratory parameters

Incidence of AEs and SAEs related to AZD8701 as monotherapy and in combination with Durvalumab in disease specific expansions treated at the MTD/OBD/MFD
From screening until 105 days after last dose of study treatment

Safety and tolerability of the MTD/OBD/MFD assessed through incidence of AEs and SAEs

Objective Response Rate according to RECIST 1.1 by investigator assessment in disease specific expansions treated at the MTD/OB/MFD
Every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death, start of subsequent anti-cancer therapy or end of study (for max 42 months)

The proportion of subjects achieving a confirmed complete or partial response according to RECIST 1.1 by investigator assessment

Secondary Endpoints

Progression-free survival according to RECIST 1.1 by investigator assessment
every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)
Duration of Response according to RECIST 1.1 by investigator assessment
every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)
Disease Control Rate at 16 weeks according to RECIST 1.1 by investigator assessment
Every 8 weeks from start of treatment until earlier of progression, death or start of subsequent anti-cancer therapy (for up to 24 weeks). Subjects followed to 24 weeks for assessment of SD for 16 weeks from first tumour assessment at 8 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MonotherapyEXPERIMENTALParticipants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.
Combination TherapyEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
AZD8701DRUGFOXP3 antisense oligonucleotide
DurvalumabBIOLOGICALanti PDL-1 monoclonal antibody
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Eligibility Criteria

Age Range18 Years to 101 Years
SexALL
Healthy VolunteersNo
Study Sites13

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 ...

Countries:United StatesCanadaFranceSpain
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Frequently asked questions about AZD8701

What is AZD8701 used for?

AZD8701 is an investigational small molecule being studied for the treatment of clear cell renal cell cancer, as well as other advanced solid tumors including non-small-cell lung cancer, triple negative breast cancer, head and neck squamous cell cancer, small cell lung cancer, gastroesophageal cancer, melanoma, and cervical cancer.

What does AZD8701 target?

AZD8701 is a small molecule developed by AstraZeneca. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated in combination with durvalumab, an anti-PD-L1 antibody, in patients with advanced solid tumors.

Who makes AZD8701?

AZD8701 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical development for the treatment of advanced solid tumors.

What phase is AZD8701 in?

AZD8701 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A first-in-human study of AZD8701, with or without durvalumab, has been completed in participants with advanced solid tumors.

What clinical trials is AZD8701 in?

AZD8701 has been studied in one clinical trial, identified as NCT04504669, titled 'First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours'. This Phase 1 trial enrolled 60 participants and has been completed. The study was conducted in the United States, Canada, France, and Spain.

Is AZD8701 the same as durvalumab?

No, AZD8701 is not the same as durvalumab. AZD8701 is an investigational small molecule being developed by AstraZeneca, while durvalumab is an anti-PD-L1 monoclonal antibody. In the clinical trial NCT04504669, AZD8701 was studied both alone and in combination with durvalumab.