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NCT Number: NCT06835569

A Study to Learn About Study Medicine ALTA3263 in Adults 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.

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Key information

Conditions

Cancer Advanced Solid Tumors Bronchial Neoplasms CRC (Colorectal Cancer) Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms NSCLC (Non-small Cell Lung Cancer) Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALTA3263

Drug

Oral ALTA3263 tablets will be administered at a protocol-defined dose

Cetuximab

Drug

Cetuximab injection for IV use will be administered at a protocol-defined dose

mFOLFOX6

Drug

modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose

Pembrolizumab

Drug

Pembrolizumab injection for IV use will be administered at a protocol-defined dose

Pemetrexed + Cisplatin /Carboplatin

Drug

Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose

mFOLFIRINOX

Drug

modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose

GnP

Drug

gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose

midazolam

Drug

Oral midazolam will be administered at a protocol-defined dose

Primary outcomes

  1. Adverse Events

    Time frame: Up to 39 months

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

  2. Dose Limiting Toxicities

    Time frame: 21 days

    Number of participants with Dose Limiting Toxicities (DLTs).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Objective Response Rate (ORR)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

  6. Duration of Response (DOR)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

  7. Progression-Free Survival (PFS)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

  8. Overall Survival (OS)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Alterome Clinical Trial Contact Center

CONTACT

[email protected]

619-768-8189

Sponsors and collaborators

Lead sponsor

Alterome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 19, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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