Home/Get Matched/NCT05489211
Phase 2Recruiting
View on ClinicalTrials.gov

Comparing 14 approaches for endometrial cancer

Official title: Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Condition: Endometrial CancerSponsor: AstraZenecaTarget enrollment: 454
  • Phase 2
  • 14 groups
  • Sites in Toronto, Montreal and 1 more city
  • Recruiting
Research Site, Toronto, OntarioResearch Site, Toronto, OntarioResearch Site, Montreal, QuebecResearch Site, Montreal, QuebecResearch Site, Québec, Quebec

Interventions (9)

  • Medication

    Datopotamab deruxtecan (Dato-DXd)

    Intravenous (IV) Antibody drug conjugate

  • Medication

    Capecitabine

    Administered orally

  • Medication

    5-Fluorouracil

    Administered as an IV

Canadian Sites (5)

5 listed, none recruiting

  • Research Site

    Toronto, Ontario

    Withdrawn
  • Research Site

    Toronto, Ontario

    Completed
  • Research Site

    Montreal, Quebec

    Withdrawn

Eligibility Criteria

See who this study is looking for45 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +There are additional substudy requirements not reflected here. This list is based solely on the master CSP
  • +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 baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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
  • +Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth controlControl groupThe group a new treatment is measured against.Read more →. Female participants must not donate, or retrieve for their own use, ova at any time during this study
  • +Capable of giving signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • +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
  • +At the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, 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
  • +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.

Exclusion

  • Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies
  • Spinal cord compression or brain metastases unless treated
  • Leptomeningeal carcinomatosis
  • Active hepatitis or uncontrolled hepatitis B or C virus infection
  • Known HIV infection that is not well controlled
  • Any evidence of diseases which, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocolProtocolThe detailed plan a study must follow.Read more →
  • 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
  • Clinically significant corneal disease
  • Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms
  • 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
  • Has severe pulmonary function compromise
  • Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more →
  • 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 enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or any concurrent anticancer treatment
  • 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
  • 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
  • History of non-infectious Interstitial lung disease (ILD)/pneumonitis, including radiation pneumonitis that required steroids
  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 14 groups in this study.

Groups A, D, F, H, K and N receive Datopotamab deruxtecan (Dato-DXd).

Registry label: A: Substudy-1A · D: Substudy-3A · F: Substudy-4A · H: Substudy-5A · K: Substudy-6C · N: Substudy-7A

Group B receives one or more of: Datopotamab deruxtecan (Dato-DXd) and Capecitabine.

Registry label: B: Substudy-2A

Group C receives one or more of: Datopotamab deruxtecan (Dato-DXd) and 5-Fluorouracil.

Registry label: C: Substudy-2B

Group E receives one or more of: Datopotamab deruxtecan (Dato-DXd) and Prednisone/ prednisolone.

Registry label: E: Substudy-3C

Group G receives one or more of: Datopotamab deruxtecan (Dato-DXd), Carboplatin and Bevacizumab.

Registry label: G: Substudy-4C

Group I receives one or more of: Datopotamab deruxtecan (Dato-DXd) and Volrustomig.

Registry label: I: Substudy-6A

Groups J and M receive one or more of: Datopotamab deruxtecan (Dato-DXd) and Rilvegostomig.

Registry label: J: Substudy-6B · M: Substudy-6E

Group L receives one or more of: Datopotamab deruxtecan (Dato-DXd), Carboplatin and Cisplatin.

Registry label: L: Substudy-6D

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 18 years to 130 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 454 people.

The study is currently expected to finish around October 2027.

The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to progressive disease or death (approximately 1 year).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Objective response rate (ORR) — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to progressive disease or death (approximately 1 year).

The number of subjects with adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →/serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → — measured over Throughout the treatment and the safety follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → 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).

PSA50 response (Substudy 3 only) — measured over From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year).

Progression free survival (PFS) response (Substudy 4C only) — measured over From baseline to progressive disease or death (approximately 1 year).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05489211 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Datopotamab deruxtecan (Dato-DXd)Drug

Intravenous (IV) Antibody drug conjugate

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About CapecitabineDrug

Administered orally

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About 5-FluorouracilDrug

Administered as an IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About VolrustomigDrug

Administered as an IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About CarboplatinDrug

Administered as an IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About BevacizumabDrug

Administered as an IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About RilvegostomigDrug

Administered as an IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Prednisone/ prednisoloneDrug

Administered orally

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About CisplatinDrug

Administered as an IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 130 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 130 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to progressive disease or death (approximately 1 year).

The study as a whole is currently expected to finish around 2027-10-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 454 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 5 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Grand Rapids, Michigan, United States; Commack, New York, United States.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Other Sites (2)

Research Site

Grand Rapids, Michigan, United States

Research Site

Commack, New York, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.