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GWN323

Phase 1

Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Feb 21, 2021

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 Enrollment92
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02740270Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and LymphomasPHASE1 COMPLETED 92Jul 22, 2016Mar 3, 2020Feb 21, 20219 United States, Canada +4
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities (DLTs) - Single Agent
21 days

Dose Limiting Toxicities

Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents
42 days

Dose Limiting Toxicities

Secondary Endpoints
Best Overall Response (BOR),
36 months
Progression Free Survival (PFS)
36 months
Serum concentration profiles of GWN323 as a single agent: Cmax
36 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Interventions
NameTypeDescription
GWN323DRUG -
PDR001DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to curative treatment by surgery. * Histologically documented advanced or metastatic solid tumors or lymphomas * Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy ...

Countries:United StatesCanadaIsraelJapanSingaporeSpain
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