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

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

San Antonio

Research Site, San Antonio, Texas, United States, 78229

Fairfax

Research Site, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alterome Therapeutics, Inc.,

Study Medical Director, STUDY_DIRECTOR, Alterome Therapeutics

Study Record Dates

2029-08