A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
NCT ID: NCT06835569
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
188 participants
INTERVENTIONAL
2025-03-05
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALTA3263 monotherapy
ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment
ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
ALTA3263 in combination with cetuximab
ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
cetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Interventions
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ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
cetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Eligibility Criteria
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Inclusion Criteria
* 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
* Known condition that prohibits the ability to swallow or absorb an oral medication.
18 Years
ALL
No
Sponsors
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Alterome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Medical Director
Role: STUDY_DIRECTOR
Alterome Therapeutics
Locations
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Research Site
Orlando, Florida, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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3263-001
Identifier Type: -
Identifier Source: org_study_id
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