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

June 8, 2026 updated by: Alterome Therapeutics, Inc.

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
448

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Research Site
      • New York, New York, United States, 10016
        • Recruiting
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Research Site #2
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALTA3263 monotherapy
ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with cetuximab
ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: cetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with mFOLFOX6 plus cetuximab
ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, and oxaliplatin (mFOLFOX6) and cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: cetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Drug: mFOLFOX6
modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with pembrolizumab
ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: Pembrolizumab
Pembrolizumab injection for IV use will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with pembrolizumab plus chemotherapy
ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: Pembrolizumab
Pembrolizumab injection for IV use will be administered at a protocol-defined dose
Drug: Pemetrexed + Cisplatin /Carboplatin
Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with mFOLFIRINOX
ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: mFOLFIRINOX
modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with mFOLFIRINOX plus cetuximab
ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: cetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Drug: mFOLFIRINOX
modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with GnP
ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: GnP
gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose
Experimental: ALTA3263 in combination with GnP plus cetuximab
ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: cetuximab
Cetuximab injection for IV use will be administered at a protocol-defined dose
Drug: GnP
gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose
Experimental: ALTA3263 Midazolam DDI Substudy
ALTA3263 and midazolam will be administered at a protocol defined schedule
Drug: ALTA3263
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Drug: Midazolam
Oral midazolam will be administered at a protocol-defined dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to 39 months
Number of participants that experience treatment-emergent adverse events (TEAEs).
Up to 39 months
Dose Limiting Toxicities
Time Frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs).
21 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months
Progression-Free Survival (PFS)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months
Overall Survival (OS)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Cmax
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Tmax
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Time Frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
AUCt
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
Time Frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose
t1/2
Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose
Objective Response Rate (ORR)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alterome Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Medical Director, Alterome Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3263-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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