Investigating ALTA3263 for advanced solid tumors with KRAS mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of ALTA3263, an oral KRAS isoform-selective inhibitor, in adults with advanced solid tumors that have KRAS mutations. It is an open-label, multicenter Phase 1/1b study designed to assess the pharmacokinetics and preliminary clinical activity of the drug. The study consists of two parts: a dose escalation phase to determine the optimal dose and a dose expansion phase to further evaluate its effects. Participants will be closely monitored for safety and treatment response.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Orlando, Florida, United States Recruiting
• Research Site
  Tampa, Florida, United States Recruiting
• Research Site
  Boston, Massachusetts, United States Recruiting
• Research Site
  Boston, Massachusetts, United States Recruiting
• Research Site
  St Louis, Missouri, United States Recruiting
• Research Site
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Alterome Clinical Trial Contact Center
• Email: clinical.trials@alterome.com
• Phone: 619-768-8189

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.