Actively Recruiting
A Phase I/IIa, Open-label Study Evaluating Oral ART0380 Alone and with Chemotherapy in Advanced or Metastatic Solid Tumors
Led by Artios Pharma Ltd · Updated on 2026-03-18
442
Participants Needed
79
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ART0380, an investigational oral drug that blocks ATR kinase, in people with advanced or metastatic solid tumors, including cancers with DNA repair defects and certain ovarian, peritoneal, fallopian tube, endometrial, colorectal, and pancreatic cancers. This open-label Phase I/IIa study aims to find safe dosing, understand side effects, and assess how well ART0380 works alone or combined with chemotherapy drugs gemcitabine or irinotecan. Participants may receive ART0380 alone or with gemcitabine or irinotecan in 21-day treatment cycles. The study includes multiple parts: initial dose testing of ART0380 alone or with chemo, expansion cohorts targeting tumors with ATM gene alterations, and randomized comparison of ART0380 plus gemcitabine versus gemcitabine alone in ovarian-related cancers. ART0380 dosing schedules vary between continuous daily or intermittent dosing. Some parts evaluate ART0380 with irinotecan in different cancers, including colorectal and pancreatic types. During the trial, participants will have regular assessments such as imaging scans to measure tumor response using RECIST 1.1 criteria, blood tests for tumor markers and drug levels, and safety monitoring for side effects. Pharmacokinetics of ART0380 will be measured at various points. Follow-up visits will track progression-free survival, overall survival, and duration of response. The study lasts up to about 24 months, with ongoing evaluations every 6 to 9 weeks depending on the part of the study.
CONDITIONS
Brief Title
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Adults aged 18 years or older
- Discontinued prior cancer treatments at least 21 days ago and recovered from side effects
- At least one tumor lesion measurable or evaluable by imaging
- Acceptable blood, kidney, liver, and clotting function
- Available tumor tissue sample for analysis
- Willing to use effective contraception during and after study treatment
- Estimated life expectancy of 12 weeks or more
- Performance status of 0-1 on the ECOG scale
- Specific additional criteria based on study part, including cancer type and prior treatments
You will not qualify if you...
- Pregnant or breastfeeding women, or planning pregnancy during study or shortly after
- Men planning to father a child during study or shortly after
- Serious systemic disorders such as recent HIV/AIDS infections, active hepatitis B or C, tuberculosis, or other malignancies not in remission
- Ongoing lung disease or pneumonitis
- Moderate to severe heart disease or significant ECG abnormalities
- Symptomatic or untreated brain or spinal metastases
- Received live vaccine within 30 days before study treatment
- Conditions or lab abnormalities that may interfere with study participation
- Recent major surgery or fluid drainage procedures before treatment
- Significant bleeding disorders or recent severe bleeding episodes
- Participation in other incompatible clinical trials
- Additional exclusions for certain study parts including specific genetic factors and medication use
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral ART0380 alone or in combination with chemotherapy drugs gemcitabine or irinotecan in 21-day cycles. ART0380 dosing schedules include intermittent (several 3-day dosing periods per cycle) or continuous daily dosing. Gemcitabine and irinotecan are administered on Days 1 and 8 of each cycle as appropriate.
Visits on Days 1 and 8 of each 21-day cycle, with additional visits as scheduled per protocol
Duration - Up to 30 days after last dose for safety follow-up; efficacy and survival follow-up may continue up to 24 months or longer
Participants are monitored for safety, adverse events, and treatment efficacy after treatment ends. Follow-up includes survival and disease progression assessments.
Periodic visits every 6 weeks for the first 18 weeks, then every 9 weeks up to approximately 24 months
Trial Site Locations
Total: 79 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Actively Recruiting
2
Mayo Clinic (Arizona)
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
6
Providence Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
7
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Actively Recruiting
8
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
9
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Actively Recruiting
10
Mayo Clinic (Florida)
Jacksonville, Florida, United States, 32224
Actively Recruiting
11
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Actively Recruiting
12
Florida Cancer Specialists
Orlando, Florida, United States, 32827
Completed
13
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
14
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
Actively Recruiting
15
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
16
Community Health Network
Indianapolis, Indiana, United States, 46250
Actively Recruiting
17
Our Lady of the Lake
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
18
Maryland Oncology Hematology - Primary
Columbia, Maryland, United States, 21044
Actively Recruiting
19
Minnesota Oncology Hematology
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
20
Mayo Clinic (Minnesota)
Rochester, Minnesota, United States, 55905
Actively Recruiting
21
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
22
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Actively Recruiting
23
Northwell Health Cancer Institute
Lake Success, New York, United States, 11042
Actively Recruiting
24
Oncology Hematology Care Primary
Cincinnati, Ohio, United States, 45242
Actively Recruiting
25
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
26
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
27
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
28
University of Pennsylvania / Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
29
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
30
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
31
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Completed
32
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
33
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
34
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
35
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
36
Texas Oncology - Northeast Texas
Flower Mound, Texas, United States, 75028
Actively Recruiting
37
Oncology Consultants
Houston, Texas, United States, 77030
Completed
38
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
39
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Actively Recruiting
40
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
41
Institut Gustave Roussy
Villejuif, Cedex, France, 94805
Actively Recruiting
42
Institut Bergonie
Bordeau, France, 33076
Actively Recruiting
43
Marseille University Hospital Timone
Marseille, France, 13005
Actively Recruiting
44
Saint-Louis Hospital
Paris, France, 75010
Actively Recruiting
45
Hospital de la Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
46
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
47
H. Parc Tauli
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
48
Next Oncology Barcelona, IOB
Barcelona, Catalonia, Spain, 08023
Actively Recruiting
49
Hospital Arnau de Vilanova
Lleida, Catalonia, Spain, 25198
Actively Recruiting
50
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
51
Next - Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
52
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
53
Clínica Universidad de Navarra
Madrid, Planta -2, Spain, 28027
Actively Recruiting
54
Hospital Clínico Universitario de Santiago (CHUS)
A Coruña, Spain, 00000
Actively Recruiting
55
Hospital Teresa Herrera (CHUAC)
A Coruña, Spain, 15006
Actively Recruiting
56
Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
57
Vall d'Hebron Institute of Oncology (VIHO)
Barcelona, Spain, 08035
Actively Recruiting
58
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
59
ICO Hospitalet
Barcelona, Spain, 08903
Actively Recruiting
60
Hospital Universitario Reina Sofia de Córdoba
Córdoba, Spain, 14004
Actively Recruiting
61
Hospital Universitari Doctor Josep Trueta- ICO de Girona
Girona, Spain, 17007
Actively Recruiting
62
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
63
MD Anderson Cancer Center (Madrid
Madrid, Spain, 28033
Actively Recruiting
64
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
65
START Madrid Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
66
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
67
START Madrid (Hospital San Chinarro)
Madrid, Spain, 28050
Actively Recruiting
68
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
69
Hospital Universitario De Navarra
Pamplona, Spain, 31008
Actively Recruiting
70
START Rioja
Rioja, Spain, 26006
Actively Recruiting
71
Hospital Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
72
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
73
Instituto Valenciano de Oncología (IVO)
Valencia, Spain, 00000
Actively Recruiting
74
Incliva Biomedical Research Institute, University of Valencia
Valencia, Spain, 46010
Actively Recruiting
75
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
76
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
77
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
78
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
79
The Christie NHS Foundation Trust - The Christie Clinic
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Sarah Cannon Development Innovations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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