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NCT06835569PHASE1Recruiting

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

Alterome Therapeutics, Inc.

Start Date

3/5/2025

Completion Date

8/1/2029

Summary

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

Detailed Description

This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. * Unresectable or metastatic disease. * Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol * Known condition that prohibits the ability to swallow or absorb an oral medication. Other inclusion/exclusion criteria may apply.

Interventions

DRUG

ALTA3263

DRUG

cetuximab

DRUG

mFOLFOX6

DRUG

Pembrolizumab

DRUG

Pemetrexed + Cisplatin /Carboplatin

DRUG

mFOLFIRINOX

DRUG

GnP

DRUG

Midazolam

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Conditions

CancerPDAC - Pancreatic Ductal AdenocarcinomaNSCLC (Non-small Cell Lung Cancer)CRC (Colorectal Cancer)Advanced Solid Tumors

Locations

Research Site

Orlando, Florida 32827

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Boston, Massachusetts 02115

United States

Research Site

St Louis, Missouri 63110

United States

Research Site

New York, New York 10016

United States

Research Site

New York, New York 10032

United States

Research Site

Durham, North Carolina 27710

United States

Research Site

Nashville, Tennessee 37203

United States

Research Site

Houston, Texas 77030

United States

Research Site #2

San Antonio, Texas 78229

United States

Research Site

San Antonio, Texas 78229

United States

Research Site

Fairfax, Virginia 22031

United States