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Urothelial CancerPhase 1/2NCT07890714

A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]

A Phase 1/2 study testing Dato-DXd, Enfortumab Vedotin (EV) and Pembrolizumab in people with Urothelial Cancer and Non-small Cell Lung Cancer, run by Daiichi Sankyo at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial is designed to assess the safety, tolerability, and antitumor activity of Datopotamab Deruxtecan (Dato-DXd) combined with other anticancer agents or as monotherapy in participants with solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer, Non-small Cell Lung Cancer
What is being tested?
Dato-DXd, Enfortumab Vedotin (EV) and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteTaiwan
Study dates
16 Oct 2026to 31 Jan 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must consent to provide archival tumor tissue sample or newly obtained pretreatment biopsy if clinically feasible and at an acceptable risk as determined by the investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 assessed no more than 14 days prior to Cycle 1 Day 1 (C1D1) (randomization for randomized cohort).
  • Has adequate organ and bone marrow function as assessed by local laboratory within 7 days prior to C1D1 (randomization for randomized cohort) as defined in the protocol.
  • Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan within 28 days before C1D1 (randomization for randomized cohort).
  • Has a life expectancy ≥3 months based on investigator's assessment.
  • Female participants must not be pregnant, does not plan to breastfeed during the trial intervention period, agrees to adhere to a contraceptive method that is highly effective and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the intervention period.
  • Male participants who intend to be sexually active with a female partner of childbearing potential should use additional barrier methods of contraception or avoid intercourse. Male participants must not freeze or donate sperm at any time during this study.

Who cannot join

  • Has unresolved toxicities from previous anticancer therapy.
  • Has spinal cord compression or clinically active central nervous system (CNS) metastases.
  • Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients.
  • Has uncontrolled or significant cardiovascular disease.
  • Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis, including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected interstitial lung disease (ILD)/pneumonitis that cannot be ruled out by imaging at screening.
  • Has clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
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  • Has clinically significant corneal disease.
  • Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
  • Has active or uncontrolled HIV infection.
  • Has active or uncontrolled hepatitis B or C virus infection.
  • Female participants who are pregnant or breastfeeding or intend to become pregnant.
  • Live vaccines within 30 days before the first dose of treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Contact for Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

Taiwan1 site, 1 recruiting

  • TCVGH (Taichung Veterans General Hospital)

    Taichung, 407219

    Jian-Ri Li

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase 1/2, Multicenter, Master Protocol Trial to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) in Participants With Solid Tumors (TROPION-PanTumor04)

This clinical trial is designed to assess the safety, tolerability, and antitumor activity of Datopotamab Deruxtecan (Dato-DXd) combined with other anticancer agents or as monotherapy in participants with solid tumors.

Read the detailed description

The study includes 2 independent substudies, which have been defined by tumor type as follows:

  1. Sub-protocol 1 Urothelial Cancer (UC) - Cohort A: Dato-DXd plus enfortumab vedotin (EV) with and without pembrolizumab in participants with locally advanced (LA)/metastatic (m) UC (LA/mUC).
  2. Sub-protocol 2 kirsten rat sarcoma viral oncogene-mutant-non-small cell lung cancer (KRAS-mutant NSCLC) - Cohort A: Dato-DXd in combination with KRAS G12C inhibitor, olomorasib in participants with LA/mNSCLC.

Each sub-study will be conducted in 2 phases: Dose finding (Phase 1) and signal finding (Phase 2).

Being tested
Dato-DXd, Enfortumab Vedotin (EV), Pembrolizumab, Olomorasib
Keywords
Dato-DXd, TROPION, DS-1062a, Datopotamab Deruxtecan, Trophoblast cell surface protein 2 (TROP2)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dato-DXdDrug

    Also called DS-1062a

    Dato-DXd will be administered as an IV infusion.

  • Enfortumab Vedotin (EV)Drug

    EV will be administered as IV infusion.

  • PembrolizumabDrug

    Pembrolizumab will be administered as an IV infusion.

  • OlomorasibDrug

    Olomorasib will be administered as oral capsules.

Study groups in NCT07890714
Study groupRoleWhat they receive
Sub-study 1: Phase 1: Part 1: Dato-DXd + EVExperimentalParticipants will be administered Dato-DXd, intravenously (IV), along with EV, administered IV.
Receives: Drug: Dato-DXd; Drug: Enfortumab Vedotin (EV)
Sub-study 1: Phase 1: Part 2: Dato-DXd + EV + PembrolizumabExperimentalBased on the maximum tolerated dose (MTD) determined by Phase 1 Part 1, participants will be administered Dato-DXd, IV, along with EV and pembrolizumab, administered IV.
Receives: Drug: Dato-DXd; Drug: Enfortumab Vedotin (EV); Drug: Pembrolizumab
Sub-study 1: Phase 2: Group A: Dato-DXd + EV + PembrolizumabExperimentalParticipants will be administered Dato-DXd, at recommended Phase 2 dose (RP2D) based on Phase 1 data, along with EV and pembrolizumab, administered IV.
Receives: Drug: Dato-DXd; Drug: Enfortumab Vedotin (EV); Drug: Pembrolizumab
Sub-study 1: Phase 2: Group B: EV + PembrolizumabActive comparatorParticipants will be administered EV, IV, along with pembrolizumab, IV.
Receives: Drug: Enfortumab Vedotin (EV); Drug: Pembrolizumab
Sub-study 2: Phase 1: Cohort A: Dato-DXd + OlomorasibExperimentalParticipants will be administered Dato-DXd, IV, along with olomorasib, administered orally.
Receives: Drug: Dato-DXd; Drug: Olomorasib
Sub-study 2: Phase 2: Dato-DXd + OlomorasibExperimentalParticipants will be administered Dato-DXd along with Olomorasib at RP2D, based on Part 1 data.
Receives: Drug: Dato-DXd; Drug: Olomorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

    DLTs are defined as the events pre-specified in the protocol and which are not clearly due to the underlying disease or extraneous causes. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

    Measured: During Cycle 1 (cycle length = 21 days)

  2. Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the start date of trial intervention to 35 days [28 (+7) days] after the last dose date of trial intervention).

    Measured: Up to approximately 2.9 years

  3. Phase 2: Objective Response Rate (ORR) as Assessed by Investigator

    Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by the investigator per RECIST v1.1.

    Measured: Up to approximately 2.9 years

Secondary outcomes (11)

  1. Phase 1: ORR as Assessed by Investigator

    ORR is defined as the percentage of participants with a BOR of confirmed CR or confirmed PR, as assessed by the investigator per RECIST v1.1.

    Measured: Up to approximately 2.9 years

  2. Phase 2: Number of Participants With TEAEs

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the start date of trial intervention to 35 days [28 (+7) days] after the last dose date of trial intervention).

    Measured: Up to approximately 2.9 years

  3. Phase 1 and 2: Duration of Response (DoR) as Assessed by the Investigator

    DoR is defined as the time (in months) from the date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression or death due to any cause.

    Measured: Up to approximately 2.9 years

  4. Phase 1 and 2: Clinical Benefit Rate (CBR) as Assessed by the Investigator

    CBR is defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) lasting ≥183 days, as assessed by the investigator per RECIST v1.1.

    Measured: Up to approximately 2.9 years

  5. Phase 1 and 2: Disease Control Rate (DCR) as Assessed by the Investigator

    DCR is defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD as assessed by the investigator per RECIST v1.1.

    Measured: Up to approximately 2.9 years

  6. Phase 1 and 2: Time to Response (TTR) as Assessed by the Investigator

    TTR is defined as the time (in months) from the start date of trial intervention (randomization for randomized cohort) to the date of the first documentation of objective response in responders (BOR of confirmed CR or confirmed PR as assessed by the investigator per RECIST v1.1).

    Measured: Up to approximately 2.9 years

  7. Phase 1 and 2: Best Percentage Change in the SoD of Measurable Tumors as Assessed by Investigator

    The best percentage change in SoD as assessed by the investigator per RECIST v1.1, defined as the percentage change in the smallest SoD from all postbaseline tumor assessments, taking as reference the baseline SoD.

    Measured: Up to approximately 2.9 years

  8. Phase 1 and 2: Progression-free Survival (PFS) as Assessed by the Investigator

    PFS is defined as the time (in months) from the start date of trial intervention (randomization for randomized cohort) to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause.

    Measured: Up to approximately 2.9 years

  9. Phase 1 and 2: Overall Survival (OS)

    OS is defined as the time (in months) from the start date of trial intervention (date of randomization for randomized cohort) to the date of death due to any cause.

    Measured: Up to approximately 2.9 years

  10. Phase 1 and 2: Plasma Concentration of Dato-DXd, Total Anti-TROP2 Antibody and MAAA-1181a

    Measured: Pre-dose and at multiple timepoints post-dose from Cycle 1 up to Cycle 8 (each cycle=21 days)

  11. Phase 1 and 2: Percentage of Participants With Positive Anti-drug Antibodies (ADAs)

    Measured: Up to approximately 2.9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start16 Oct 2026
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07890714
Sponsor's protocol ID
DS1062-270
Other IDs
2024-519729-39-00
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dato-DXd, Enfortumab Vedotin (EV) and Pembrolizumab in people with Urothelial Cancer and Non-small Cell Lung Cancer, run by Daiichi Sankyo at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: During Cycle 1 (cycle length = 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07890714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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