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LTT462

Phase 2

Melanoma | Small molecule | Oncology |Novartis AG|Trials Updated: Mar 12, 2026

LTT462 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Mar 2016

LTT462 target and mechanism

ModalitySmall molecule

Also known as Rineterkib

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

LTT462 clinical trials

LTT462 · 1 trial · 1 indication

Phase 2 1
NCT04417621Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic MelanomaMelanoma
ACTIVE NOT_RECRUITING134 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate
35 months

Confirmed ORR using RECIST v1.1, per local assessment

Secondary Endpoints

Duration of Reposnse (DOR)
4 years
Progression Free Survival (PFS)
4 years
Disease Control Rate (DCR)
3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LXH254 + LTT462EXPERIMENTAL -
LXH254 + trametinibEXPERIMENTAL -
LXH254 + ribociclibEXPERIMENTAL -

Interventions

NameTypeDescription
LXH254DRUGLXH254 will be supplied as tablet for oral use.
LTT462DRUGLTT462 will be supplied as hard gelatin capsule for oral use.
TrametinibDRUGTrametinib will be supplied as film-coated tablet for oral use
RibociclibDRUGRibociclib will be supplied in tablets and hard gelatin capsules.
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Eligibility Criteria

Age Range12 Years to 120 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight \> 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma Previously treated for unresectable or metastatic melanoma: * Participants with NRAS mutation: * Participants must h...

Countries:United StatesArgentinaAustraliaBelgiumFranceGermanyIsraelItalyNetherlandsNorwaySwitzerlandUnited Kingdom
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Frequently asked questions about LTT462

What is LTT462?

LTT462 is an investigational small molecule developed by Novartis AG for the treatment of melanoma. It is being studied in patients with previously treated unresectable or metastatic melanoma. LTT462 is a biomarker-selected therapy, meaning trial enrollment is guided by specific molecular characteristics of a patient's tumor.

What is LTT462 used for in melanoma?

LTT462 is being evaluated for the treatment of previously treated unresectable or metastatic melanoma. It is studied as part of a combination regimen in a Phase 2 trial. The trial enrolls patients whose tumors meet biomarker selection criteria, and it is currently active but no longer recruiting participants.

Who makes LTT462?

LTT462 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating LTT462 in melanoma.

What phase is LTT462 in?

LTT462 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 study is active but not recruiting, and no trials of LTT462 have been completed to date.

What clinical trials is LTT462 in?

LTT462 is being studied in the Phase 2 trial NCT04417621, titled Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma. The trial has enrolled 134 patients across the United States, Argentina, Australia, Belgium, France, Germany, Israel, Italy, the Netherlands, Norway, Switzerland, and the United Kingdom.

Is LTT462 a randomized trial?

Yes. The Phase 2 trial of LTT462, NCT04417621, is a randomized, controlled study. It is not double blinded. The trial enrolled 134 patients with previously treated unresectable or metastatic melanoma and is currently active but not recruiting new participants.