A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
NCT ID: NCT04657068
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
502 participants
INTERVENTIONAL
2020-12-13
2026-12-31
Brief Summary
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* 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
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Detailed Description
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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) by immunohistochemistry, and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A1
Part A1 evaluated intermittent and continuous dosing of ART0380 monotherapy. Treatment was given in 21-day cycles.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Part A2
Part A2 evaluated intermittent dosing of ART0380 in combination with gemcitabine in 21-day cycles.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Gemcitabine
Gemcitabine was administered on Days 1 and 8 of a 21-day cycle.
Part A3
Part A3 evaluated intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Part B1
In Part B1, up to 7 cohorts enrolled participants with solid cancers with alterations in the ATM (ataxia-telangiectasia mutated) gene likely to predict for loss of ATM protein will be treated with either
* ART0380 monotherapy Or
* ART0380 in combination with irinotecan
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Part B2
In Part B2, participants with high grade serous ovarian, primary peritoneal, or fallopian tube carcinoma were randomized (open label) 1:1 to either ART0380 in combination with gemcitabine or gemcitabine alone.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Gemcitabine
Gemcitabine was administered on Days 1 and 8 of a 21-day cycle.
Part B3
in Part B3, participants with persistent or recurrent endometrial cancer (EC) received ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Part B4
In Part B4, participants with advanced or metastatic solid tumors received ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Part B5
In Part B5, participants with colorectal cancer (CRC) will receive ART0380 in combination with irinotecan on a 21-day cycle.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Part B6
In Part B6, participants with pancreatic ductal adenocarcinoma (PDAC) or acinar cell carcinoma will receive ART0380 in combination with irinotecan on a 21-day cycle.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Part A3 Fed/Fast
Part A3 Fed/Fast will evaluate intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles in a fasting or fed state.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Part B7
In Part B7, participants with colorectal cancer (CRC) will receive ART0380 in combination with irinotecan on a 21-day cycle.
ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Interventions
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ART0380
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
Gemcitabine
Gemcitabine was administered on Days 1 and 8 of a 21-day cycle.
Irinotecan
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
•Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted.
* 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.
* 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.
* 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, defined as disease progression within 6 months of last receipt of platinum-based chemotherapy. 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
* Persistent or recurrent endometrial cancer with biological selection.:
* Patients should have received taxane/platinum chemotherapy, unless contraindicated.
* Measurable disease.
* 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
* 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.
* Part B5 (3L) only:
* Patients must have received a maximum of exactly 2 prior chemotherapy regimens for the treatment of CRC which must have included a fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated or unavailable
* Part B7 (2L) only:
* Patients must have received exactly 1 prior chemotherapy regimen for the treatment of CRC which must have included a fluoropyrimidine unless contraindicated or unavailable
* Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene
* Participants should have previously received prior lines of therapy in this setting
* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1
* Serum albumin ≥3g/dL within 7 days prior to first dose.
Exclusion Criteria
* 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
* 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
* Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.
* Patients receiving 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 only: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer
18 Years
ALL
No
Sponsors
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Artios Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Johnson, MD
Role: STUDY_CHAIR
Tennessee Oncology
Antonio Gonzalez, MD, PHD
Role: STUDY_CHAIR
Clinica Universidad de Navarra, Madrid
Susanna Ulahannan, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma University
Kim Reiss Binder, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania / Abramson Cancer Center
Locations
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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
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Florida Cancer Specialists
Orlando, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
Our Lady of the Lake
Baton Rouge, Louisiana, United States
Maryland Oncology Hematology - Primary
Columbia, Maryland, United States
Minnesota Oncology Hematology
Maple Grove, Minnesota, United States
Mayo Clinic (Minnesota)
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
Oncology Hematology Care Primary
Cincinnati, Ohio, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania / Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Northeast Texas
Flower Mound, Texas, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Institut Gustave Roussy
Villejuif, Cedex, France
Institut Bergonie
Bordeau, , France
Hospital General Universitario de Elche
Elche, Alicante, Spain
H. Parc Tauli
Sabadell, Barcelona, Spain
Next Oncology Barcelona, IOB
Barcelona, Catalonia, Spain
Hospital Arnau de Vilanova
Lleida, Catalonia, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Next - Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Clínica Universidad de Navarra
Madrid, Planta -2, Spain
START Rioja
Rioja, Spain, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Spain, Spain
Hospital Teresa Herrera (CHUAC)
A Coruña, , Spain
Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol
Badalona, , Spain
Vall d'Hebron Institute of Oncology (VIHO)
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
ICO Hospitalet
Barcelona, , Spain
Hospital Universitario Reina Sofia de Córdoba
Córdoba, , Spain
Hospital Universitari Doctor Josep Trueta- ICO de Girona
Girona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
MD Anderson Cancer Center (Madrid
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
START Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
START Madrid (Hospital San Chinarro)
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario De Navarra
Pamplona, , Spain
Hospital Virgen Macarena
Seville, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Incliva Biomedical Research Institute, University of Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Guy's and St Thomas' NHS Foundation Trust
London, London, United Kingdom
The Christie NHS Foundation Trust - The Christie Clinic
Manchester, United Kingdom, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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ART0380C001
Identifier Type: -
Identifier Source: org_study_id
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