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IPH5201

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Aug 15, 2022

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 Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04261075IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.PHASE1 COMPLETED 57 — — Mar 3, 2020Jun 16, 2022Aug 15, 20228 United States, France +2
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Study Endpoints
Primary Endpoints
Incidence of adverse events as a measure of safety
From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months

The primary endpoint is safety as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs).

Incidence of clinically significant laboratory values as a measure of safety
From time of informed consent through 12 weeks after the last dose of investigational product, approximately 7 months

Number of subjects with clinically significant laboratory values from baseline including blood counts, liver, kidney and pancreas tests, electrolytes, and blood clotting.

Incidence of clinically significant electrocardiogram (ECG) abnormalities as a measure of safety
From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximatley 7 months

12 lead ECGs will be measured to identify clinical significant abnormalities including ECGs that demonstrate a QTcF value \>500ms, 2 additional 12-lead ECGs should be obtained over a 30 minute time period to confirm prolongation based on the average QTcF value

Secondary Endpoints
OR (Objective Response; Response evaluation criteria in solid tumors [RECIST] v1.1)
From time of consent until date of first documented disease progression (approximately 4 months)
DC (Disease Control; RECIST 1.1)
From time of consent until date of first documented disease progression (approximately 4 months)
Half-life of IPH5201
From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IPH5201 monotherapy dose escalationEXPERIMENTALIPH5201 monotherapy
IPH5201 dose escalation with durvalumabEXPERIMENTALIPH5201 plus durvalumab
IPH5201 dose escalation with durvalumab + oleclumabEXPERIMENTALIPH5201 plus durvalumab and oleclumab
Interventions
NameTypeDescription
IPH5201BIOLOGICALAscending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years
durvalumabBIOLOGICALDurvalumab Q3W for a maximum of 2 years
oleclumabBIOLOGICALOleclumab Q3W for a maximum of 2 years
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Eligibility Criteria
Age Range18 Years — 101 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Adult subjects; age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Subjects diagnosed with advanced solid tumors. * For Part 1 and Part 2 (IPH5201 in monotherapy or combined with durvalumab):Subjects must be refractory to standard therap...

Countries:United StatesFranceSpainSwitzerland
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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
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