A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations

A Phase I Dose Finding Study of Oral LTT462 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations - CLTT462X2101

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223152

Enrollment

Registered

2016-03-25

Start date

2016-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor

Interventions

investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ECOG (Eastern Cooperative Oncology Group) performance status <=1 Patients must be willing and able to undergo study required biopsies. Presence of at least one measurable lesion according to RECIST v1.1. Documented MAPK pathway alteration

Exclusion criteria

Exclusion criteria: Prior treatment with ERK inhibitors. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study. Patients with malignant disease other than that being treated in the study. Clinically significant cardiac disease.

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
efficacy pharmacokinetics pharmacodynamics pharmacogenomics	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Contacts

Public ContactSanae Moizumi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026