RECRUITING

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

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Conditions

CancerPDAC - Pancreatic Ductal AdenocarcinomaNSCLC (non-small Cell Lung Cancer)CRC (colorectal Cancer)Advanced Solid TumorsKRAS mutationNSCLCNon-small cell lung cancerColorectal cancerPancreatic ductal adenocarcinomaColorectal carcinomaPancreatic cancerPancreatic carcinomaSolid tumorsKRASMutationMetastaticAdvanced unresectableNeoplasmsNeoplasms by SiteCarcinomaNon-small cell lung carcinomaNon-small cell lung neoplasmPancreatic neoplasmLung neoplasmColorectal neoplasmColon neoplasmMutant KRASKRAS amplification

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06835569

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Unresectable or metastatic disease.
  3. * Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. * Adequate organ function
  1. * Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
  2. * Known condition that prohibits the ability to swallow or absorb an oral medication.

Contacts and Locations

Study Contact

Alterome Clinical Trial Contact Center
CONTACT
619-768-8189
clinical.trials@alterome.com

Principal Investigator

Study Medical Director
STUDY_DIRECTOR
Alterome Therapeutics

Study Locations (Sites)

Research Site
San Antonio, Texas, 78229
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Alterome Therapeutics, Inc.

  • Study Medical Director, STUDY_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 Registration Dates

Study Start Date2025-03
Study Completion Date2029-08

Study Record Updates

Study Start Date2025-03
Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

  • KRAS mutation
  • NSCLC
  • Non-small cell lung cancer
  • Colorectal cancer
  • Pancreatic ductal adenocarcinoma
  • Colorectal carcinoma
  • Pancreatic cancer
  • Pancreatic carcinoma
  • Solid tumors
  • KRAS
  • Mutation
  • Metastatic
  • Advanced unresectable
  • Neoplasms
  • Neoplasms by Site
  • Carcinoma
  • Non-small cell lung carcinoma
  • Non-small cell lung neoplasm
  • Pancreatic neoplasm
  • Lung neoplasm
  • Colorectal neoplasm
  • Colon neoplasm
  • Mutant KRAS
  • KRAS amplification

Additional Relevant MeSH Terms

  • Cancer
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • NSCLC (non-small Cell Lung Cancer)
  • CRC (colorectal Cancer)
  • Advanced Solid Tumors