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

Recruiting now · Phase 1

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

In brief

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

Key facts

Study ID

NCT06835569

Run by

Alterome Therapeutics, Inc.

People needed

448

Starts

2025-03-05

Expected to finish

2029-08-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Orlando, Florida, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — St Louis, Missouri, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Durham, North Carolina, United States (enrolling)
• Research Site — Nashville, Tennessee, United States (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site #2 — San Antonio, Texas, United States (enrolling)
• Research Site — San Antonio, Texas, United States (enrolling)
• Research Site — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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