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AZD8701

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04504669First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid TumoursPHASE1 COMPLETED 60 — — Aug 18, 2020Oct 7, 2024Nov 5, 202413 United States, Canada +2
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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 — 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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