Actively Recruiting
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Led by Artios Pharma Ltd · Updated on 2026-03-18
442
Participants Needed
79
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
- Discontinued all previous cancer treatments for at least 21 days or 5 half-lives and recovered from acute effects to CTCAE Grade 3
- Palliative radiotherapy completed at least 1 week before study treatment
- Prior PARP inhibitor treatment if BRCA mutation or HRD positive cancer, unless contraindicated
- At least 1 radiologically evaluable lesion suitable for RECIST v1.1 or PCWG-3 evaluation
- Acceptable blood, kidney, liver, and coagulation function
- Available non-irradiated tumor tissue sample for analysis
- Use of highly effective contraception plus barrier method during and after study (duration depends on treatment)
- Estimated life expectancy of at least 12 weeks
- Willing and reliable to participate for study duration and follow procedures
- ECOG performance status 0-1
- For Part A1: advanced/metastatic cancer refractory to or lacking standard therapies
- For Part A2: advanced/metastatic cancer appropriate for gemcitabine treatment
- For Part A3: advanced/metastatic cancer appropriate for irinotecan treatment; ability to eat high-fat meal if in food effect cohort
- For Part B1: advanced/metastatic solid tumors with ATM gene alterations and measurable disease; prior irinotecan treatment allowed for combination arms
- For Part B2: high grade serous ovarian, fallopian tube or primary peritoneal carcinoma; platinum-resistant disease; prior PARP inhibitor treatment unless contraindicated; measurable disease
- For Part B3: persistent or recurrent endometrial cancer; prior taxane/platinum chemotherapy unless contraindicated; measurable disease
- For Part B4: advanced or metastatic solid cancers with biological selection; prior PD-1/PDL-1 inhibitor if approved; measurable disease; ECOG 0-1
- For Part B5: metastatic colorectal cancer with ATM alterations; prior chemotherapy lines as appropriate; measurable disease
- For Part B6: metastatic or locally advanced pancreatic ductal adenocarcinoma or acinar cell carcinoma with ATM alterations; prior chemotherapy regimen and disease progression or intolerance; measurable disease; serum albumin 3g/dL within 7 days before first dose
You will not qualify if you...
- Pregnant or breastfeeding women or planning pregnancy during study or within 7 months after last treatment
- Men planning to father a child during study or within 5 months after last treatment
- Serious systemic disorders compromising study adherence including recent HIV/AIDS-related infections, hepatitis B or C, chronic tuberculosis, or prior malignancy not in remission
- Ongoing interstitial lung disease or pneumonitis
- Moderate or severe cardiovascular disease
- Severe or clinically significant valvulopathy
- Major clinically significant ECG abnormalities
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease needing treatment
- Received live vaccine within 30 days before study treatment
- Any condition, therapy, or lab abnormality interfering with study participation or safety
- Major surgery within 4 weeks or minor surgery within 1 week prior to study
- Drainage of ascites, pleural effusion or pericardial fluid within 4 weeks before first dose
- Significant bleeding disorder or Grade 3 bleeding in past 12 weeks
- Concurrent participation in incompatible clinical trials
- For Parts A3, B1, B5, B6 with irinotecan: clinical deterioration symptoms
- Known homozygous or combined heterozygous UGT1A1 *6/*28 genotypes
- Use of strong UGT1A1 inhibitors within 2 weeks before first dose
- For Part A3 fed-fasted cohort: use of acid reducing agents within 1 week before first dose
- For Part B6: neuroendocrine or adenosquamous carcinoma pancreatic cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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