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Taking people in TaiwanPhase 1/2

Tests datopotamab deruxtecan alone or combined in adults with solid tumors

Tests datopotamab deruxtecan, alone or with other drugs, in adults with urothelial or lung cancer.

Key facts

Who runs it
Daiichi Sankyo
Where
Taichung, TaiwanSee the site
Registry title
A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]
Status
Recruiting
Phase
Phase 1/2
People taking part
268 people, planned
Started
16 Oct 2026
Expected to end
31 Jan 2030
Type of study
Interventional, 6 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Dato-DXd
  • Enfortumab Vedotin (EV)
  • Pembrolizumab
  • Olomorasib
Record updated
22 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with solid tumors, including urothelial cancer and non-small cell lung cancer, to test Dato-DXd alone or with other cancer drugs.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Solid tumors; conditions listed are urothelial cancer and non-small cell lung cancer. The record gives no further stage details.
Earlier treatment
Side effects from earlier cancer treatment must have resolved. No live vaccines within 30 days before the first dose.

Main reasons for not taking part

  • Cancer spread to the brain or spinal cord compression that is active
  • Past or current lung inflammation such as interstitial lung disease or pneumonitis
  • Uncontrolled or significant heart disease
  • Active or uncontrolled HIV, hepatitis B or hepatitis C infection
  • Pregnant or breastfeeding, or planning to become pregnant

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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 take part

  • Has unresolved toxicities from previous anticancer therapy
  • Live vaccines within 30 days before the first dose of treatment
  • 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
  • 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
  • Has spinal cord compression or clinically active central nervous system (CNS) metastases
  • Female participants who are pregnant or breastfeeding or intend to become pregnant

Where in Taiwan

  • TCVGH (Taichung Veterans General Hospital)Taichung, TaiwanContact: Jian-Ri Li (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 6 groups in the trial

  • Sub-study 1: Phase 1: Part 1: Dato-DXd + EVTreatment being tested

    Participants will be administered Dato-DXd, intravenously (IV), along with EV, administered IV.

    Treatment: Dato-DXd and Enfortumab Vedotin (EV)

  • Sub-study 1: Phase 1: Part 2: Dato-DXd + EV + PembrolizumabTreatment being tested

    Based 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.

    Treatment: Dato-DXd, Enfortumab Vedotin (EV), and Pembrolizumab

  • Sub-study 1: Phase 2: Group A: Dato-DXd + EV + PembrolizumabTreatment being tested

    Participants will be administered Dato-DXd, at recommended Phase 2 dose (RP2D) based on Phase 1 data, along with EV and pembrolizumab, administered IV.

    Treatment: Dato-DXd, Enfortumab Vedotin (EV), and Pembrolizumab

  • Sub-study 1: Phase 2: Group B: EV + PembrolizumabExisting treatment, for comparison

    Participants will be administered EV, IV, along with pembrolizumab, IV.

    Treatment: Enfortumab Vedotin (EV) and Pembrolizumab

  • Sub-study 2: Phase 1: Cohort A: Dato-DXd + OlomorasibTreatment being tested

    Participants will be administered Dato-DXd, IV, along with olomorasib, administered orally.

    Treatment: Dato-DXd and Olomorasib

  • Sub-study 2: Phase 2: Dato-DXd + OlomorasibTreatment being tested

    Participants will be administered Dato-DXd along with Olomorasib at RP2D, based on Part 1 data.

    Treatment: Dato-DXd and Olomorasib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Tests datopotamab deruxtecan alone or combined in adults with solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
22 October 2026