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Study of ALTA3263 for Advanced Solid Tumors with KRAS Mutations

This study is for adults with advanced solid tumors, including pancreatic, lung, and colorectal cancers, that have a specific genetic change called a KRAS mutation. It's testing a new targeted therapy called ALTA3263, which you take by mouth. Researchers want to understand how safe ALTA3263 is and what side effects it might cause, both alone and when given with other common cancer treatments like cetuximab, mFOLFOX6, pembrolizumab, or pemetrexed + cisplatin/carboplatin. The study will also look at how well ALTA3263 works. To join, your cancer must be advanced or have spread, and molecular testing must confirm a KRAS mutation. The study aims to enroll 448 participants.

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know which treatment you are receiving. It is a Phase 1/1b study, which typically involves a smaller number of participants to find the right dose and check for safety.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events (side effects) will be monitored for up to 39 months, and dose-limiting toxicities will be measured for 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06835569

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

Recruiting
PHASE1Ages 18+InterventionalTreatment
Alterome Therapeutics, Inc.
~448 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:ALTA3263cetuximabmFOLFOX6PembrolizumabPemetrexed + Cisplatin /CarboplatinmFOLFIRINOX

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over Up to 39 months
+1 more outcome measured

Conditions

Cancer
PDAC - Pancreatic Ductal Adenocarcinoma
NSCLC (Non-small Cell Lung Cancer)
CRC (Colorectal Cancer)
Advanced Solid Tumors

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRas

Where it's being run

12 sites across 8 states
Texas3
Massachusetts2
New York2
Florida1
Missouri1
North Carolina1
Tennessee1
Virginia1

Study leadership

  • Study Medical Director · STUDY_DIRECTOR · Alterome Therapeutics

Who to contact

Alterome Clinical Trial Contact Center
[email protected]
619-768-8189
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Adverse EventsUp to 39 months

    Number of participants that experience treatment-emergent adverse events (TEAEs).

  • Dose Limiting Toxicities21 days

    Number of participants with Dose Limiting Toxicities (DLTs).