New pill shows promise against tough cancers – early trial underway

NCT ID NCT04657068

Disease control Sponsor: Artios Pharma Ltd Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests an experimental drug called ART0380, taken as a pill, in people with advanced or metastatic solid tumors (cancers that have spread). The drug targets a protein that helps cancer cells repair their DNA. Researchers want to find the safest dose when given alone or with standard chemotherapies (gemcitabine or irinotecan). About 442 participants will join this early-phase trial to check safety, side effects, and whether the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ART0380 (an experimental drug taken by mouth that targets a protein called ATR kinase, involved in cancer cell growth)
What this could lead to: If it works, this could lead to a new treatment option for people with advanced solid tumors, especially ovarian, colorectal, or pancreatic cancers.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or may have significant side effects. It is not yet known if ART0380 works better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 542 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General 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 Additional inclusion criteria for participants in dose escalation (Part A1): * Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study * Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale Additional inclusion criteria for participants in dose escalation (Part A2): •Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted. Additional inclusion criteria for participants in dose escalation (Part A3): * Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted. * For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site. Additional inclusion criteria for participants in dose expansion (Part B1): * Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1 * For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available. * Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted. * For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed. Additional inclusion criteria for participants in dose expansion (Part B2): * Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated. * Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy * Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy). * No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated. * Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1 Inclusion criteria specific to Part B3 * Persistent or recurrent endometrial cancer with biological selection.: * Patients should have received taxane/platinum chemotherapy, unless contraindicated. * Measurable disease. Inclusion criteria specific to Part B4 * Advanced or metastatic solid cancers of any histology with biological selection * If a PD-1/PDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study. * Radiologically evaluable disease * Performance status of 0-1 on the ECOG scale Inclusion criteria specific to Part B5 * Metastatic CRC with alterations to the ATM gene * Participants should have previously received appropriate prior lines of therapy in this setting. * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. * Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC. * Serum albumin ≥3g/dL within 7 days prior to first dose. * ECOG Performance Status must be stable for at least 2 weeks prior to enrollment. * Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease Inclusion criteria specific to Part B6: * Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene * Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant/adjuvant therapy with recurring occurring \<6 months following completion of this treatment. * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions. * Serum albumin ≥3g/dL within 7 days prior to first dose. * ECOG Performance Status must be stable for at least 2 weeks prior to enrollment. * Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease. General Exclusion Criteria: * 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 * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate * Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study * Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment. * A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment * Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study Additional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan): * Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening. * Patients who are known to be homozygous for both UGT1A1 \*6 and \*28 (UGT1A1 7/7 genotype), or simultaneously heterozygous for both UGT1A1 \*6 and \*28. * Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment * Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded * Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer * Parts B5 and B6: Initiation of opioids in the previous 2 weeks. * Parts B5 and B6: Weight loss \>10% in the previous 8 weeks. * Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.

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Conditions

The condition(s) this trial relates to.

acinar cell carcinoma cancer colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm fallopian tube cancer fallopian tube neoplasm fallopian tube serous adenocarcinoma hereditary sensory and autonomic neuropathy metastatic malignant neoplasm metastatic neoplasm neoplasm Neoplasm Metastasis ovarian cancer ovarian serous adenocarcinoma pancreatic ductal adenocarcinoma primary peritoneal carcinoma primary peritoneal serous/papillary carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acinar cell carcinoma Advanced cancer Endometrial cancer Fallopian tube cancer Metastatic cancer Metastatic colorectal cancer Ovarian cancer Pancreatic ductal adenocarcinoma Primary peritoneal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

79 sites in 4 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Baptist Cancer Center
COMPLETED

Memphis, Tennessee, 38120, United States
Beatson West of Scotland Cancer Centre
RECRUITING

Glasgow, G12 0YN, United Kingdom
Cancer Specialists of North Florida
RECRUITING

Jacksonville, Florida, 32256, United States
Clínica Universidad de Navarra
RECRUITING

Madrid, Planta -2, 28027, Spain
Community Health Network
RECRUITING

Indianapolis, Indiana, 46250, United States
Florida Cancer Specialists
RECRUITING

Fort Myers, Florida, 33901, United States
Florida Cancer Specialists
COMPLETED

Orlando, Florida, 32827, United States
Florida Cancer Specialists
RECRUITING

Sarasota, Florida, 34232, United States
Florida Cancer Specialists
RECRUITING

West Palm Beach, Florida, 33401, United States
Guy's and St Thomas' NHS Foundation Trust
RECRUITING

London, SE1 9RT, United Kingdom
H. Parc Tauli
RECRUITING

Sabadell, Barcelona, 08208, Spain
Hematology Oncology Associates of Central New York
RECRUITING

East Syracuse, New York, 13057, United States
Hope and Healing Cancer Services
RECRUITING

Hinsdale, Illinois, 60521, United States
Hospital Arnau de Vilanova
RECRUITING

Lleida, Catalonia, 25198, Spain
Hospital Clinic de Barcelona
RECRUITING

Barcelona, 08036, Spain
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING

El Palmar, Murcia, 30120, Spain
Hospital Clínico Universitario de Santiago (CHUS)
RECRUITING

A Coruña, 00000, Spain
Hospital General Universitario Gregorio Marañón
RECRUITING

Madrid, 28007, Spain
Hospital General Universitario de Elche
RECRUITING

Elche, Alicante, 03203, Spain
Hospital Saint-Antoine
RECRUITING

Paris, 75012, France
Hospital Teresa Herrera (CHUAC)
RECRUITING

A Coruña, 15006, Spain
Hospital Universitari Doctor Josep Trueta- ICO de Girona
RECRUITING

Girona, 17007, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario De Navarra
RECRUITING

Pamplona, 31008, Spain
Hospital Universitario La Paz
RECRUITING

Madrid, Madrid, 28046, Spain
Hospital Universitario Marques de Valdecilla
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Miguel Servet
RECRUITING

Zaragoza, 50009, Spain
Hospital Universitario Reina Sofia de Córdoba
RECRUITING

Córdoba, 14004, Spain
Hospital Universitario Virgen de la Victoria
RECRUITING

Málaga, 29010, Spain
Hospital Virgen Macarena
RECRUITING

Seville, 41009, Spain
Hospital Virgen del Rocío
RECRUITING

Seville, 41013, Spain
Hospital de la Pitié-Salpêtrière
RECRUITING

Paris, 75013, France
ICO Hospitalet
RECRUITING

Barcelona, 08903, Spain
Incliva Biomedical Research Institute, University of Valencia
RECRUITING

Valencia, 46010, Spain
Institut Bergonie
RECRUITING

Bordeau, 33076, France
Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol
RECRUITING

Badalona, 08916, Spain
Institut Gustave Roussy
RECRUITING

Villejuif, Cedex, 94805, France
Instituto Valenciano de Oncología (IVO)
RECRUITING

Valencia, 00000, Spain
MD Anderson Cancer Center (Madrid
RECRUITING

Madrid, 28033, Spain
Marseille University Hospital Timone
RECRUITING

Marseille, 13005, France
Mary Crowley Cancer Research
RECRUITING

Dallas, Texas, 75230, United States
Maryland Oncology Hematology - Primary
RECRUITING

Columbia, Maryland, 21044, United States
Mayo Clinic (Arizona)
RECRUITING

Scottsdale, Arizona, 85259, United States
Mayo Clinic (Florida)
RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic (Minnesota)
RECRUITING

Rochester, Minnesota, 55905, United States
Minnesota Oncology Hematology
RECRUITING

Maple Grove, Minnesota, 55369, United States
Next - Hospital Quironsalud Madrid
RECRUITING

Pozuelo de Alarcón, Madrid, 28223, Spain
Next Oncology Barcelona, IOB
RECRUITING

Barcelona, Catalonia, 08023, Spain
Northwell Health Cancer Institute
RECRUITING

Lake Success, New York, 11042, United States
Oncology Consultants
COMPLETED

Houston, Texas, 77030, United States
Oncology Hematology Care Primary
RECRUITING

Cincinnati, Ohio, 45242, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Our Lady of the Lake
RECRUITING

Baton Rouge, Louisiana, 70808, United States
Providence Medical Foundation
RECRUITING

Santa Rosa, California, 95403, United States
Rocky Mountain Cancer Center
RECRUITING

Denver, Colorado, 80218, United States
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
START Madrid (Hospital San Chinarro)
RECRUITING

Madrid, 28050, Spain
START Madrid Fundacion Jimenez Diaz
RECRUITING

Madrid, 28040, Spain
START Rioja
RECRUITING

Rioja, 26006, Spain
Saint-Louis Hospital
RECRUITING

Paris, 75010, France
Sansum Clinic
RECRUITING

Santa Barbara, California, 93105, United States
Sarah Cannon Research Institute UK
RECRUITING

London, W1G 6AD, United Kingdom
Sarah Cannon Research Institute at HealthONE
RECRUITING

Denver, Colorado, 80218, United States
Stephenson Cancer Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Taylor Cancer Research Center
RECRUITING

Maumee, Ohio, 43537, United States
Tennessee Oncology, PLLC
RECRUITING

Chattanooga, Tennessee, 37404, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
RECRUITING

Dallas, Texas, 75246, United States
Texas Oncology - Central/South Texas
RECRUITING

Austin, Texas, 78705, United States
Texas Oncology - Northeast Texas
RECRUITING

Flower Mound, Texas, 75028, United States
Texas Oncology - San Antonio
RECRUITING

San Antonio, Texas, 78240, United States
The Christie NHS Foundation Trust - The Christie Clinic
RECRUITING

Manchester, M20 4BX, United Kingdom
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
USC Norris Comprehensive Cancer Center
RECRUITING

Los Angeles, California, 90033, United States
University of Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35294-3300, United States
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
RECRUITING

Little Rock, Arkansas, 72205, United States
University of Pennsylvania / Abramson Cancer Center
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Utah Cancer Specialists
RECRUITING

Salt Lake City, Utah, 84106, United States
Vall d'Hebron Institute of Oncology (VIHO)
RECRUITING

Barcelona, 08035, Spain
Vanderbilt Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
Washington University
RECRUITING

St Louis, Missouri, 63110, United States

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