Recent Updates
Recently added Catalysts

durvalumab + rHu

Phase 1

Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07391670A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous DurvalumabPHASE1 RECRUITING 40 — — Mar 31, 2026Aug 30, 2027May 15, 202619 Australia, Georgia +3
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area under the concentration-time curve
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the AUC of SC durvalumab.

Observed lowest concentration before the next dose is administered (Ctrough)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the Ctrough of SC durvalumab

Secondary Endpoints
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Maximum observed concentration (Cmax)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Time to reach maximum concentration following drug administration (tmax)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: SC Durvalumab DL1EXPERIMENTALParticipants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Part 1: SC Durvalumab DL2EXPERIMENTALParticipants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Part 2: Expansion Cohort, SC Durvalumab Dose Level XEXPERIMENTALParticipants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Interventions
NameTypeDescription
SC durvalumab + rHuDRUGDurvalumab + rHu will be administered subcutaneously.
IV durvalumabDRUGDurvalumab will be administered intravenously.
TremelimumabDRUGTremelimumab will be administered to participants with unresectable HCC as an IV infusion.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of ≥ 12 weeks at enrolment. * Adequate organ and marrow function. * Minimum body weight \> 30 kg. Part 1 only: Locally Advanced Unresectable (Stage III) NSCLC Participants - * Histo...

Countries:AustraliaGeorgiaPolandSouth KoreaTaiwan
Unlock Eligibility Criteria
Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07391670Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07391670studyFirstPostDate: changed