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

Phase 1

Recruiting

• Conditions: Cancer; CRC (Colorectal Cancer); PDAC - Pancreatic Ductal Adenocarcinoma; Advanced Solid Tumors; NSCLC (Non-small Cell Lung Cancer)
• Interventions: Drug: ALTA3263

• Registration Number: NCT06835569
• Lead Sponsor: Alterome Therapeutics, Inc.

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

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-19
• Study Start: 2025-03-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-10-21
• Last Update Posted: 2025-10-23
• Primary Completion: 2029-05
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities	21 days	Number of participants with Dose Limiting Toxicities (DLTs).
Adverse Events	Up to 39 months	Number of participants that experience treatment-emergent adverse events (TEAEs).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Fairfax, Virginia, United States