Phase
Condition
Ovarian Cancer
Biliary Tract Cancer
Gastric Cancer
Treatment
5-Fluorouracil
Durvalumab
Saruparib
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male and female, ≥ 18 years
Documented advanced or metastatic malignancy
Eastern Cooperative Oncology Group performance status of 0 or 1 with nodeterioration over the 2 weeks prior to baseline or day of first dosing
All participants must provide a tumour sample for tissue-based analysis
At least 1 measurable lesion not previously irradiated, except Substudy 3 (ProstateCancer) which allows participants with non measurable bone metastatic disease
Adequate bone marrow reserve and organ function
Minimum life expectancy of 12 weeks
At the time of screening, contraceptive use by men or women should be consistentwith local regulations regarding the methods of contraception for thoseparticipating in clinical studies
All women of childbearing potential must have a negative serum pregnancy testdocumented during screening
Female participants must be 1 year post-menopausal, surgically sterile, or using 1highly effective form of birth control. Female participants must not donate, orretrieve for their own use, ova at any time during this study
Male participants who intend to be sexually active with a female partner ofchildbearing potential must be surgically sterile, avoid intercourse, or use ahighly effective method of contraception. Male participants must not freeze ordonate sperm at any time during this study.
Capable of giving signed informed consent
Provision of signed and dated written optional genetic research informed consentprior to collection of samples for optional genetic research that supports theGenomic Initiative
Exclusion
Key Exclusion Criteria:
Any evidence of diseases which, in the investigator's opinion, makes it undesirablefor the participant to participate in the study or that would jeopardize compliancewith the protocol
History of another primary malignancy except for adequately resected basal cellcarcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancytreated with curative intent
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, notyet improved
Irreversible toxicity that is not reasonably expected to be exacerbated by studyintervention in the opinion of the investigator, for example hearing loss
Spinal cord compression or brain metastases unless treated
Leptomeningeal carcinomatosis
Clinically significant corneal disease
Active hepatitis or uncontrolled hepatitis B or C virus infection
Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, forexample prodromal symptoms
Known HIV infection that is not well controlled
Known active tuberculosis infection
Mean resting corrected QTcF > 470 ms
In the judgement of the investigator, history of QT prolongation associated withother medications that required discontinuation of that medication, or any currentconcomitant medication known to prolong the QT interval and cause TdP
In the judgement of the investigator, congenital long QT syndrome, family history oflong QT syndrome, or unexplained sudden death under 40 years of age in first-degreerelatives
Uncontrolled or significant cardiac diseases
History of non-infectious Interstitial lung disease (ILD)/pneumonitis that requiredsteroids
Has severe pulmonary function compromise
Prior exposure to chloroquine/hydroxychloroquine without an adequate treatmentwashout period
Receipt of live, attenuated vaccine within 30 days prior to the first dose of studyintervention
Prior exposure to anticancer therapies without an adequate treatment washout periodprior to enrolment or any concurrent anticancer treatment
Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or tomore than 30% of the bone marrow within ≤ 4 weeks before the first dose of studyintervention
Major surgical procedure or significant traumatic injury within ≤ 3 weeks of thefirst dose of study intervention or an anticipated need for major surgery during thestudy
Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload
Herbal or natural products intended as treatment or prophylaxis for any type ofcancer that may interfere with the activity of the study intervention
Previous treatment in the present study
Participation in another clinical study with a study intervention or investigationalmedicinal device administered in the last 4 weeks prior to first dose of studyintervention or concurrent enrolment in another clinical study
Severe hypersensitivity to Dato-DXd or any of the excipients, including but notlimited to polysorbate 80 or other monoclonal antibodies
Involvement in the planning and/or conduct of the study
Judgment by the investigator that the participant should not participate in thestudy if the participant is unlikely to comply with study procedures, restrictions,and requirements
Females that are pregnant, breastfeeding, or planning to become pregnant
Female participants should refrain from breastfeeding from enrolment throughout thestudy and for at least 7 months after last dose of Dato-DXd
Study Design
Study Description
Connect with a study center
Research Site
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Research Site
Montreal, Quebec H2X 0A9
CanadaSite Not Available
Research Site
Quebec, G1J 1Z4
CanadaActive - Recruiting
Research Site
Changsha, 410013
ChinaSite Not Available
Research Site
Chongqing, 400030
ChinaActive - Recruiting
Research Site
Guangzhou, 510060
ChinaActive - Recruiting
Research Site
Hangzhou, 310020
ChinaActive - Recruiting
Research Site
Hefei, 230001
ChinaSite Not Available
Research Site
Shanghai, 200032
ChinaSite Not Available
Research Site
Shenyang, 110016
ChinaSite Not Available
Research Site
Wuhan, 430079
ChinaSite Not Available
Research Site
Xi'an, 710000
ChinaSite Not Available
Research Site
Zhengzhou, 450052
ChinaActive - Recruiting
Research Site
Bordeaux, 33076
FranceActive - Recruiting
Research Site
Lyon, 69373
FranceActive - Recruiting
Research Site
Marseille, 13273
FranceSite Not Available
Research Site
Suresnes, 92150
FranceActive - Recruiting
Research Site
Berlin, 10117
GermanySite Not Available
Research Site
Essen, 45136
GermanySite Not Available
Research Site
Hannover, 30625
GermanySite Not Available
Research Site
München, 81377
GermanySite Not Available
Research Site
München, 81377
GermanySite Not Available
Research Site
Regensburg, 93053
GermanySite Not Available
Research Site
Firenze, 50139
ItalySite Not Available
Research Site
Genova, 16132
ItalySite Not Available
Research Site
Milan, 20141
ItalySite Not Available
Research Site
Milano, 20132
ItalyActive - Recruiting
Research Site
Napoli, 80131
ItalyActive - Recruiting
Research Site
Rome, 00168
ItalySite Not Available
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Kashiwa, 277-8577
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Nagoya-shi, 464-8681
JapanActive - Recruiting
Research Site
Shinagawa-ku, 142-8666
JapanActive - Recruiting
Research Site
Suita-shi, 565-0871
JapanActive - Recruiting
Research Site
Seodaemun-gu, 03722
Korea, Republic ofSite Not Available
Research Site
Seoul, 03722
Korea, Republic ofActive - Recruiting
Research Site
Gliwice, 44-102
PolandActive - Recruiting
Research Site
Kraków, 31-501
PolandSite Not Available
Research Site
Kraków, 31-501
PolandActive - Recruiting
Research Site
PoznaÅ", 61-866
PolandSite Not Available
Research Site
Poznań, 61-866
PolandSite Not Available
Research Site
Warszawa, 02-781
PolandActive - Recruiting
Research Site
Šódź, 92-213
PolandSite Not Available
Research Site
Łódź, 92-213
PolandSite Not Available
Research Site
Barcelona, 8035
SpainActive - Recruiting
Research Site
Cordoba, 14004
SpainActive - Recruiting
Research Site
Madrid, 28046
SpainActive - Recruiting
Research Site
Málaga, 29010
SpainSite Not Available
Research Site
Málaga, 29010
SpainActive - Recruiting
Research Site
Pamplona, 31008
SpainActive - Recruiting
Research Site
Sevilla, 41013
SpainActive - Recruiting
Research Site
Basel, 4031
SwitzerlandSite Not Available
Research Site
Bellinzona, 6500
SwitzerlandSite Not Available
Research Site
St. Gallen, 9007
SwitzerlandSite Not Available
Research Site
Liou Ying Township, 736
TaiwanActive - Recruiting
Research Site
Taipei, 11259
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Ankara, 06620
TurkeyActive - Recruiting
Research Site
Edirne, 22030
TurkeyActive - Recruiting
Research Site
Kadıkoy/Istanbul, 34722
TurkeySite Not Available
Research Site
Kadıkoy/Istanbul, 34722
TurkeyActive - Recruiting
Research Site
Karsiyaka, 35575
TurkeyActive - Recruiting
Research Site
Konya, 42080
TurkeyActive - Recruiting
Research Site
Pamukkale, 20070
TurkeyActive - Recruiting
Research Site
Samsun, 55139
TurkeySite Not Available
Research Site
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Research Site
Dundee, DD1 9SY
United KingdomActive - Recruiting
Research Site
London, EC1A 7BE
United KingdomActive - Recruiting
Research Site
Manchester, M20 4BX
United KingdomActive - Recruiting
Research Site
Los Angeles, California 90095
United StatesActive - Recruiting
Research Site
San Diego, California 92103
United StatesSite Not Available
Research Site
Santa Rosa, California 95403
United StatesActive - Recruiting
Research Site
Indianapolis, Indiana 46202
United StatesSite Not Available
Research Site
Muncie, Indiana 47303
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesSite Not Available
Research Site
Boston, Massachusetts 02114
United StatesSite Not Available
Research Site
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Research Site
East Brunswick, New Jersey 08816
United StatesActive - Recruiting
Research Site
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Research Site
Commack, New York 11725
United StatesActive - Recruiting
Research Site
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Research Site
Columbus, Ohio 43219
United StatesActive - Recruiting
Research Site
Portland, Oregon 97239
United StatesSite Not Available
Research Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Madison, Wisconsin 53792
United StatesActive - Recruiting
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