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IDH305

Phase 1

Advanced Malignancies That Harbor IDHR132 Mutations | Small molecule | Oncology |Novartis AG|Last Updated: Apr 13, 2026

Target and mechanism

Molecular targetIDH1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment166

FDA Designations

No designations recorded

Clinical trial landscape

IDH305 · 1 trial · 1 indication

Phase 1 1
NCT02381886A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 MutationsAdvanced Malignancies That Harbor IDHR132 Mutations
ACTIVE NOT_RECRUITING166 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Advanced Malignancies That Harbor IDHR132 MutationsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incident rate of dose limiting toxicities (DLTs)
21 days

To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Secondary Endpoints

Incidence of adverse events (AEs)
30 months
Plasma PK parameters (AUC, Cmax, Tmax)
30 months
Changes of 2-hydroxyglutarate concentration in patient specimens
30 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IDH305EXPERIMENTAL -

Interventions

NameTypeDescription
IDH305DRUG -
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Documented IDH1R132-mutant tumors * ECOG performance status ≤ 2 Exclusion Criteria: * Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients) * Medical conditions that would prevent the patient's participation ...

Countries:United StatesAustraliaBelgiumCanadaGermanyNetherlandsSingaporeSpain
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Frequently asked questions about IDH305

What is IDH305 used for?

IDH305 is an investigational small molecule being developed for the treatment of advanced malignancies that harbor IDH1R132 mutations. It is currently in Phase 1 clinical development for this oncology indication.

How does IDH305 work?

IDH305 targets the IDH1R132 mutation, which is a specific genetic alteration found in certain advanced malignancies. By targeting this mutation, the drug is designed to address cancers that carry this particular genetic change.

Who is developing IDH305?

IDH305 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development.

What phase is IDH305 in?

IDH305 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling patients, though recruitment is currently not active.

What clinical trials is IDH305 in?

IDH305 is being studied in a single Phase 1 clinical trial with the identifier NCT02381886. This trial is investigating the drug in patients with advanced malignancies that harbor IDH1R132 mutations, with an enrollment of 166 participants across multiple countries.

Is IDH305 the same as IDH305?

IDH305 is the drug name used in clinical development. No alternative names have been reported for this investigational agent. It is being studied under the trial identifier NCT02381886 for advanced malignancies with IDH1R132 mutations.