RecruitingPhase 1NCT06835569

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations


Sponsor

Alterome Therapeutics, Inc.

Enrollment

188 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study tests ALTA3263, a new oral drug designed to block KRAS — one of the most common cancer-driving mutations — in patients with various advanced solid tumors that have not responded to standard treatments. **You may be eligible if...** - You have been diagnosed with a solid tumor (any type) that has a KRAS mutation, confirmed by approved genetic testing - Your cancer is unresectable (cannot be removed surgically) or has spread to other parts of the body - You have progressed on, cannot tolerate, or have declined standard treatment options - You have a good performance status (ECOG 0 or 1) - You have adequate organ function **You may NOT be eligible if...** - You have received a prior KRAS inhibitor (with some exceptions) - You have a condition that prevents you from swallowing or absorbing oral medication - You have uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALTA3263

Oral ALTA3263 tablets will be administered at a protocol-defined dose

DRUGcetuximab

Cetuximab injection for IV use will be administered at a protocol-defined dose


Locations(10)

Research Site

Orlando, Florida, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Nashville, Tennessee, United States

Research Site

Houston, Texas, United States

Research Site #2

San Antonio, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06835569


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