Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin… (NCT07129993) | Clinical Trial Compass
RecruitingPhase 2/3
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
United States, Austria, China630 participantsStarted 2025-09-26
Plain-language summary
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant does not have radiological metastasis of a proven prostate cancer.
. Participant with nonmetastatic prostate cancer do not have rising PSA (as determined using local testing by a validated or approved test method) defined as follows:
. Participant does not currently receive androgen deprivation therapy for the treatment of prostate cancer.
. GFR \<60 mL/min (GFR may be estimated by calculated CrCl using the Cockcroft-Gault formula, Modification of Diet in Renal Disease, or 24-hour urine)
Exclusion criteria
. History of an allogeneic bone marrow or solid organ transplant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate - Part A (Phase 2)
Timeframe: From Phase 2 randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, up to approximately 34 months
2
Progression Free Survival as Assessed by Blinded Independent Central Review (BICR) - Part B (Phase 3)
Timeframe: From Phase 3 randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, up to approximately 38 months
3
Overall Survival - Part B (Phase 3)
Timeframe: From Phase 3 randomization to death due to any cause, up to approximately 38 months
. Concomitant treatment with any prohibited medications in this protocol.
. Prior TROP2 directed ADC therapy.
. QTcF interval \>470 ms based on the average of triplicate 12-lead (ECG per local read) at screening.
. Myocardial infarction within 6 months prior to randomization.
. Uncontrolled angina pectoris within 6 months prior to randomization.
. NYHA Class 3 or 4 congestive heart failure at screening.
. Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).