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A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
Led by Alterome Therapeutics, Inc. · Updated on 2026-05-06
188
Participants Needed
12
Research Sites
13 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of ALTA3263 in adults with advanced solid tumors that have KRAS mutations. This open-label, multicenter Phase 1/1b study focuses on tumors that are unresectable or metastatic and have progressed after standard treatments. The study aims to understand the effects and behavior of ALTA3263, an orally taken inhibitor targeting multiple mutant forms of KRAS, alone and combined with cetuximab. The study includes two parts: Part 1 involves dose escalation of ALTA3263, and Part 1b involves dose expansion. Participants will receive ALTA3263 continuously at a dose defined by their assigned group. Some participants will receive ALTA3263 alone, while others will receive it alongside cetuximab, an intravenous injection. Both treatments are given continuously according to the study protocol. Participants will be monitored for safety and side effects up to 39 months, with a focus on dose-limiting toxicities during the first 21 days. Researchers will collect blood samples to measure how the drug is processed in the body during the first treatment cycle. They will also evaluate tumor response, duration of response, progression-free survival, and overall survival over the study period. The study involves regular assessments to track safety, drug levels, and clinical outcomes throughout participation.
CONDITIONS
Brief Title
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of a solid tumor malignancy with a KRAS mutation identified by molecular testing
- Disease that is unresectable or metastatic
- Progressed on, intolerant to, or declined prior standard-of-care therapy appropriate to tumor type and stage
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Prior treatment with a KRAS inhibitor, except certain exceptions described in the full protocol
- Known condition that prevents swallowing or absorption of oral medication
- Other exclusion criteria may apply as detailed in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral ALTA3263 alone or in combination with cetuximab at doses defined by the study protocol. Treatment is continuous based on cohort assignment and monitored for safety and clinical response.
Visits at least on Day 1 and Day 15 of each 21-day cycle for assessments
Trial Site Locations
Total: 12 locations
1
Research Site
Orlando, Florida, United States, 32827
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2
Research Site
Boston, Massachusetts, United States, 02114
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3
Research Site
Boston, Massachusetts, United States, 02115
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4
Research Site
St Louis, Missouri, United States, 63110
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5
Research Site
New York, New York, United States, 10016
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6
Research Site
New York, New York, United States, 10032
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7
Research Site
Durham, North Carolina, United States, 27710
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8
Research Site
Nashville, Tennessee, United States, 37203
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9
Research Site
Houston, Texas, United States, 77030
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10
Research Site #2
San Antonio, Texas, United States, 78229
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11
Research Site
San Antonio, Texas, United States, 78229
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12
Research Site
Fairfax, Virginia, United States, 22031
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Research Team
A
Alterome Clinical Trial Contact Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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