Recent Updates
Recently added Catalysts

ION537

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Ionis Pharmaceuticals, Inc.|Last Updated: Dec 21, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

ION537 · 1 trial · 1 indication

Phase 1 1
NCT04659096A Study of ION537 in Patients With Molecularly Selected Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED15 Analytics
PHASE1COMPLETED
A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors
Advanced Solid Tumors
NCT0465909615
Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Treatment-emergent Serious Adverse Event (TESAE), Graded by Severity
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Number of Participants With Dose-limiting Toxicities (DLTs)
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Percentage of Participants With Complete Response (CR)
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Percentage of Participants With Partial Response (PR)
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Percentage of Participants With Stable Disease (SD)
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Area Under the Plasma Concentration-Time Curve from Hour Zero to Hour 24 AUC[0-24] for ION537
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Maximum Observed Plasma Concentration (Cmax) for ION537
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Inhibition of Yes-associated Protein (YAP1) Expression
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)

Secondary Endpoints

Percentage of Participants With CR
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Percentage of Participants With PR
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Percentage of Participants With SD
Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ION537EXPERIMENTALMultiple ascending doses of ION537 will be administered by intravenous (IV) injection on Days 1, 4, 8, 11, 15, and 22 in Cycle 1 and weekly dosing in each subsequent cycle until disease progression.

Interventions

NameTypeDescription
ION537DRUGION537 will be administered by IV injection.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males and females ≥ 18 years old 2. Participants must have histological diagnosis of local advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent 3. Participants must be in need of systemic treatment for their cance...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced 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
Unlock Competitive Intelligence

Frequently asked questions about ION537

What is ION537 used for?

ION537 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and has been evaluated in a completed trial involving patients with molecularly selected advanced solid tumors.

Who makes ION537?

ION537 is developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical research to evaluate the drug's safety and efficacy in oncology.

What phase is ION537 in?

ION537 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains under clinical investigation for advanced solid tumors.

What clinical trials is ION537 in?

ION537 has one completed clinical trial, NCT04659096, titled "A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors." This Phase 1 study enrolled 15 participants in the United States and was not randomized or blinded.

Is ION537 the same as any other drug?

No alternative names for ION537 have been disclosed. The drug is identified by its code name ION537 and is being developed by Ionis Pharmaceuticals for the treatment of advanced solid tumors.