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.
Plain-language title generated from the registry record
Registry title: A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]
Key facts
- Where
- Taichung, TaiwanSee the site
- Phase
- Phase 1/2
Where in Taiwan
- TCVGH (Taichung Veterans General Hospital)Taichung, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daiichi Sankyo
- Trial code
- NCT07890714EU 2024-519729-39-00
- Record updated
- 22 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.