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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

448

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Alterome Therapeutics, Inc.

Investigators

  • 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)

March 5, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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