A Study To Learn About Study Medicine ALTA3263 In Adults With Advanced Solid Tumors With KRAS Mutations

Study Overview

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

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

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.

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

DRUG: ALTA3263

3263-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-09
First Submitted that Met QC Criteria 2025-02-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-11
First Posted (ACTUAL) 2025-02-19	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ALTA3263 ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment	DRUG: ALTA3263 Oral ALTA3263 tablets will be administered at a protocol-defined dose

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: ALTA3263

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

DRUG: ALTA3263

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

Primary Outcome Measures	Measure Description	Time Frame
Adverse Events	Number of participants that experience treatment-emergent adverse events (TEAEs).	Up to 39 months
Dose Limiting Toxicities	Number of participants with Dose Limiting Toxicities (DLTs).	21 days

Secondary Outcome Measures	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Cmax	Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Tmax	Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)	AUCt	Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)	t1/2	Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose
Objective Response Rate (ORR)	Assess per RECIST 1.1	Up to 39 months
Duration of Response (DOR)	Assess per RECIST 1.1	Up to 39 months
Progression-Free Survival (PFS)	Assess per RECIST 1.1	Up to 39 months
Overall Survival (OS)	Assess per RECIST 1.1	Up to 39 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Alterome Clinical Trial Contact Center

Phone Number: 619-768-8189

Email: clinical.trials@alterome.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Study Medical Director, Alterome Therapeutics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record