Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
NCT ID: NCT05489211
Last Updated: 2025-07-11
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
PHASE2
582 participants
INTERVENTIONAL
2022-09-06
2026-08-19
Brief Summary
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Detailed Description
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This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), colorectal cancer (CRC) (Substudy 5), urothelial cancer (Substudy 6), and biliary tract cancer (Substudy 7) in the advanced or metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated (for all substudies except Substudy 1 and Substudy 7).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Substudy 1 (Endometrial): MONO: Dato-DXd
Substudy 2 (Gastric): COMBO: Dato-DXd + capecitabine, Dato-DXd + 5-FU
Substudy 3 (mCRPC): MONO: Dato-DXd; COMBO: Dato-DXd + prednisone/prednisolone
Substudy 4 (Ovarian): MONO: Dato-DXd; COMBO: Dato-DXd + carboplatin + bevacizumab --\> Dato-DXd + bevacizumab
Substudy 5 (CRC): MONO: Dato-DXd; COMBO: Dato-DXd + 5-FU + leucovorin + bevacizumab or Dato-DXd + capecitabine + bevacizumab
Substudy 6 (Urothelial): MONO: Dato-DXd; COMBO: Dato-DXd + volrustomig, Dato-DXd + rilvegostomig, Dato-DXd + carboplatin or cisplatin
Substudy 7 (BTC): MONO: Dato-DXd
TREATMENT
NONE
Study Groups
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Substudy-1A
Dato-DXd will be evaluated as monotherapy
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Substudy-2A
Dato-DXd in combination with capecitabine will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Capecitabine
Administered orally
Substudy-2B
Dato-DXd in combination with 5-FU will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
5-Fluorouracil
Administered as an IV
Substudy-3A
Dato-DXd will be evaluated as monotherapy
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Substudy-3C
Dato-DXd will be evaluated in combination with prednisone/prednisolone
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Prednisone/ prednisolone
Administered orally
Substudy-4A
Dato-DXd will be evaluated as monotherapy
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Substudy-4C
Dato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Carboplatin
Administered as an IV
Bevacizumab
Administered as an IV
Substudy-5A
Dato-DXd will be evaluated as monotherapy
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Substudy-5B
Dato-DXd + 5-FU + LV + bevacizumab OR Dato-DXd + capecitabine + bevacizumab will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Capecitabine
Administered orally
5-Fluorouracil
Administered as an IV
Leucovorin LV
Administered as an IV
Bevacizumab
Administered as an IV
Substudy-6A
Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Volrustomig
Administered as an IV
Substudy-6B
Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Rilvegostomig
Administered as an IV
Substudy-6C
Dato-DXd will be evaluated as monotherapy
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Substudy-6D
Dato-DXd in combination with carboplatin or cisplatin will be evaluated
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Carboplatin
Administered as an IV
Cisplatin
Administered as an IV
Substudy-7A
Dato-DXd will be evaluated as monotherapy
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Interventions
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Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
Capecitabine
Administered orally
5-Fluorouracil
Administered as an IV
Volrustomig
Administered as an IV
Carboplatin
Administered as an IV
Leucovorin LV
Administered as an IV
Bevacizumab
Administered as an IV
Rilvegostomig
Administered as an IV
Prednisone/ prednisolone
Administered orally
Cisplatin
Administered as an IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented advanced or metastatic malignancy
* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration 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 (Prostate Cancer) 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 consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* All women of childbearing potential must have a negative serum pregnancy test documented during screening
* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study
* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.
* Capable of giving signed informed consent
* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative
Exclusion Criteria
* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent
* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved
* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention 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, for example 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 with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP
* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives
* Uncontrolled or significant cardiac diseases
* History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
* Has severe pulmonary function compromise
* Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment
* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention
* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
* 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 of cancer 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 investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study
* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited 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 the study 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 the study and for at least 7 months after last dose of Dato-DXd
18 Years
130 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Lead, MD
Role: PRINCIPAL_INVESTIGATOR
AstraZeneca
Locations
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Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
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Santa Rosa, California, United States
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Muncie, Indiana, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Grand Rapids, Michigan, United States
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East Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Commack, New York, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Madison, Wisconsin, United States
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Changsha, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Zhengzhou, , China
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Bordeaux, , France
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Lyon, , France
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Marseille, , France
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Suresnes, , France
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Berlin, , Germany
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Essen, , Germany
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Hanover, , Germany
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München, , Germany
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Regensburg, , Germany
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Rome, , Italy
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Chūōku, , Japan
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Kashiwa, , Japan
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Kōtoku, , Japan
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Nagoya, , Japan
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Shinagawa-ku, , Japan
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Suita-shi, , Japan
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Gliwice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Basel, , Switzerland
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Bellinzona, , Switzerland
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Sankt Gallen, , Switzerland
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Liou Ying Township, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Kadıkoy/Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Pamukkale, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Dundee, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-509436-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-000776-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D926UC00001
Identifier Type: -
Identifier Source: org_study_id
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