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

NCT ID: NCT06835569

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2029-08-31

Brief Summary

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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

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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.

Conditions

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Cancer PDAC - Pancreatic Ductal Adenocarcinoma NSCLC (Non-small Cell Lung Cancer) CRC (Colorectal Cancer) Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALTA3263 monotherapy

ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment

Group Type EXPERIMENTAL

ALTA3263

Intervention Type DRUG

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

ALTA3263 in combination with cetuximab

ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

Group Type EXPERIMENTAL

ALTA3263

Intervention Type DRUG

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

cetuximab

Intervention Type DRUG

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

Interventions

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ALTA3263

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

Intervention Type DRUG

cetuximab

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alterome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Medical Director

Role: STUDY_DIRECTOR

Alterome Therapeutics

Locations

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Research Site

Orlando, Florida, United States

Site Status RECRUITING

Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

Nashville, Tennessee, United States

Site Status RECRUITING

Research Site

Houston, Texas, United States

Site Status RECRUITING

Research Site

San Antonio, Texas, United States

Site Status RECRUITING

Research Site

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alterome Clinical Trial Contact Center

Role: CONTACT

619-768-8189

Other Identifiers

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3263-001

Identifier Type: -

Identifier Source: org_study_id

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