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

Alterome Therapeutics, Inc.

Status and phase

Enrolling

Phase 1

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Advanced Solid Tumors

Cancer

NSCLC (non-small Cell Lung Cancer)

CRC (colorectal Cancer)

Treatments

Drug: ALTA3263

Study type

Interventional

Funder types

Industry

Identifiers

NCT06835569

3263-001

Details and patient eligibility

About

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

Full 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, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.