Trial · NCT07890714
A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]
NCT07890714, Phase 1, Phase 2, Recruiting, Daiichi Sankyo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]. Trials, record NCT07890714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890714
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]
- NCT number
- NCT07890714
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 268 participants, estimated
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Urothelial Cancer, Non-small Cell Lung Cancer
- Interventions
- Dato-DXd, Enfortumab Vedotin (EV), Pembrolizumab, Olomorasib
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) | During Cycle 1 (cycle length = 21 days) | 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. |
| Primary | Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 2.9 years | 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). |
| Primary | Phase 2: Objective Response Rate (ORR) as Assessed by Investigator | Up to approximately 2.9 years | 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. |
| Secondary | Phase 1: ORR as Assessed by Investigator | Up to approximately 2.9 years | 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. |
| Secondary | Phase 2: Number of Participants With TEAEs | Up to approximately 2.9 years | 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). |
| Secondary | Phase 1 and 2: Duration of Response (DoR) as Assessed by the Investigator | Up to approximately 2.9 years | 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. |
| Secondary | Phase 1 and 2: Clinical Benefit Rate (CBR) as Assessed by the Investigator | Up to approximately 2.9 years | 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. |
| Secondary | Phase 1 and 2: Disease Control Rate (DCR) as Assessed by the Investigator | Up to approximately 2.9 years | 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. |
| Secondary | Phase 1 and 2: Time to Response (TTR) as Assessed by the Investigator | Up to approximately 2.9 years | 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). |
| Secondary | Phase 1 and 2: Best Percentage Change in the SoD of Measurable Tumors as Assessed by Investigator | Up to approximately 2.9 years | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07890714
GET https://conductscience.org/api/trials/v1/NCT07890714/registered