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GWN323

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

GWN323 · 1 trial · 2 indications

Phase 1 1
NCT02740270Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and LymphomasSolid Tumors
COMPLETED92 Analytics
PHASE1COMPLETED
Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas
Solid Tumors
NCT0274027092
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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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about GWN323

What is GWN323 used for?

GWN323 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development for oncology indications, specifically advanced malignancies and lymphomas. The drug is not yet approved and remains under investigation in clinical trials.

Who makes GWN323?

GWN323 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this investigational oncology drug candidate.

What phase is GWN323 in?

GWN323 is in Phase 1 clinical development. A Phase I/Ib study of the drug, both alone and in combination with another agent, has been completed. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is GWN323 in?

GWN323 has one completed clinical trial registered as NCT02740270, a Phase I/Ib study of GWN323 alone and in combination with PDR001 in patients with advanced malignancies and lymphomas. The trial enrolled 92 participants across multiple countries including the United States, Canada, Israel, Japan, Singapore, and Spain.

Is GWN323 the same as PDR001?

No, GWN323 is not the same as PDR001. GWN323 is the investigational drug being studied, while PDR001 is a separate agent used in combination with GWN323 in the clinical trial NCT02740270. The study evaluated GWN323 both as a monotherapy and in combination with PDR001.