A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Recruiting · NCT06835569 · Interventional (participants receive a specific treatment) · Lead sponsor: Alterome Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
- ther inclusion/exclusion criteria may apply.
Where it is running
12 locations listed across 8 US states.
- Research Site - Orlando, Florida, United States
- Research Site - Boston, Massachusetts, United States
- Research Site - Boston, Massachusetts, United States
- Research Site - St Louis, Missouri, United States
- Research Site - New York, New York, United States
- Research Site - New York, New York, United States
- Research Site - Durham, North Carolina, United States
- Research Site - Nashville, Tennessee, United States
- Research Site - Houston, Texas, United States
- Research Site #2 - San Antonio, Texas, United States
- Research Site - San Antonio, Texas, United States
- Research Site - Fairfax, Virginia, United States