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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

NCT04657068•Artios Pharma Ltd

View on ClinicalTrials.gov

Summary

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan

Detailed Description

ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of Ataxia telangiectasia and Rad3-related (ATR). ART0380 is being developed as an oral anti-cancer agent for the treatment of participants with cancers that harbor defects in deoxyribonucleic acid (DNA) repair and in combination with agents including those that cause DNA damage. This study is an open-label Phase I/IIa study designed to evaluate the safety, tolerability, PK and preliminary efficacy of ART0380 as monotherapy or in combination with gemcitabine or irinotecan in participants with advanced or metastatic solid tumors, advanced or solid tumors that fail to express Ataxia-Telangiectasia Mutated protein kinase (ATM), and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent
•Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
•If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated
•At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)
•Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor
•Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.
•Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose.
•Estimated life expectancy of ≥12 weeks
•Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
•Performance status of 0-1 on the ECOG Scale
+28 more criteria

Exclusion Criteria

•Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.
•Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment
•Men who plan to father a child while in the study or within5 months after the last administration of study treatment
•Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV/AIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission
•Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
•Moderate or severe cardiovascular disease
•Valvulopathy that is severe, moderate, or deemed clinically significant
•Documented major electrocardiogram (ECG) abnormalities which are clinically significant
•Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
•Received a live vaccine within 30 days before the first dose of study treatment
+10 more criteria

Locations (79)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic (Arizona)

Scottsdale, Arizona, United States

University of Arkansas - Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sansum Clinic

Santa Barbara, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Mayo Clinic (Florida)

Jacksonville, Florida, United States

Key Dates

Start Date

January 27, 2021

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

March 18, 2026

Enrollment

442

ESTIMATED participants

Conditions

Advanced CancerMetastatic CancerOvarian CancerPrimary Peritoneal CancerFallopian Tube CancerEndometrial CancerMetastatic Colorectal CancerPancreatic Ductal AdenocarcinomaAcinar Cell Carcinoma

Interventions

ART0380

DRUG

Gemcitabine

DRUG

Irinotecan

DRUG

Contacts

Sarah Cannon Development Innovations

CONTACT

844-710-6157 SCRI.InnovationsMedical@scri.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

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