NCT05489211
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
Recruiting
PHASE2Ages 18+InterventionalTreatmentAstraZeneca
~454 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Datopotamab deruxtecan (Dato-DXd)Capecitabine5-FluorouracilVolrustomigCarboplatinBevacizumab
At a glance
Recruiting sites
56 of 96 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over From baseline to progressive disease or death (approximately 1 year)
+3 more outcomes measured
Conditions
Where it's being run
96 sites across 27 statesChina14
Turkey (Türkiye)8
Italy7
Japan6
Spain6
United Kingdom6
Germany5
Poland5
Study leadership
- Global Clinical Lead, MD · PRINCIPAL_INVESTIGATOR · AstraZeneca
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male and female, ≥ 18 years
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
Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
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, including radiation 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
What this trial measures
- Objective response rate (ORR)From baseline to progressive disease or death (approximately 1 year)
Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1.
- The number of subjects with adverse events/serious adverse eventsThroughout the treatment and the safety follow-up period 28 [+ 7] days after the discontinuation of all study interventions, except durvalumab, nivolumab, and bevacizumab for which it will be 90 [+ 7] days (approximately 1 year)
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
- PSA50 response (Substudy 3 only)From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)
Proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.
- Progression free survival (PFS) response (Substudy 4C only)From baseline to progressive disease or death (approximately 1 year)
PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.