About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ALTA3263
  • cetuximab
  • mFOLFOX6
  • Pembrolizumab
  • Pemetrexed + Cisplatin /Carboplatin
  • mFOLFIRINOX
  • GnP
  • Midazolam

Treatment groups

448 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Locations

12
Florida
Research Site32827, Orlando United States
Massachusetts
Research Site02114, Boston United States
Research Site02115, Boston United States
Missouri
Research Site63110, St Louis United States

Sponsors and collaborators

Alterome Therapeutics, Inc.

Lead sponsor