RecruitingPhase 1Phase 2NCT05898399

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Sponsor

Artios Pharma Ltd

Enrollment

181 participants

Start Date

Jun 30, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Solid Tumor

Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ART6043 and a drug called Olaparib for people with advanced solid tumor and metastatic solid tumor. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGART6043

ART6043 will be given orally.

DRUGOlaparib

Olaparib will be given orally.

Locations(18)

South Texas Accelerated Research Therapeutics (START) - Midwest

Grand Rapids, Michigan, United States

Memorial Sloan-Kettering Cancer Center (MSKCC)

New York, New York, United States

Stephenson Cancer Center - Oncology

Oklahoma City, Oklahoma, United States

Jefferson University Hospitals - Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

SCRI oncology partners

Nashville, Tennessee, United States

Mary Crowley Cancer Center - Clinic

Dallas, Texas, United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Hospital Universitario Clínico San Cecilio

Granada, Andalusia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital San Pedro de Alcántara

Cáceres, Extremadura, Spain

Hospital Clinico San Carlos

San Carlos, Madrid, Spain

Hospital Universitario de Jerez de la Frontera

Cadiz, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

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NCT05898399

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