Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Adva… (NCT05489211) | Clinical Trial Compass
RecruitingPhase 2
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
United States, Canada, China454 participantsStarted 2022-09-06
Plain-language summary
TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.
Who can participate
Age range
18 Years – 130 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.
Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP
* Male and female, ≥ 18 years
* Documented advanced or metastatic malignancy
* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing
* All participants must provide a tumour sample for tissue-based analysis
* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease
* Adequate bone marrow reserve and organ function
* Minimum life expectancy of 12 weeks
* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* All women of childbearing potential must have a negative serum pregnancy test documented during screening
* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study
* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.
* Capable of gi…
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.
1This trial is testing Dato-DXd both on its own and combined with other anti-cancer agents — given my specific diagnosis, which approach or substudy would apply to me, and what does that mean for what I'd actually be receiving?
2Since this is a Phase 2 trial, the safety profile of Dato-DXd is still being actively studied — what are the most important side effects my doctor would want to watch for with this drug, especially for my cancer type?
3The trial is measuring objective response rate as a primary outcome — based on what's been seen so far in similar patients, what realistic level of tumor response has been observed with Dato-DXd, and how does that compare to my current standard treatment options?
4This trial covers several different cancer types and substudies, so what would the monitoring schedule and visit frequency actually look like for me, and is that manageable given my situation?
5Before considering this trial, are there standard-of-care treatments I should try first, or is my doctor's view that a trial like this could be a reasonable path to explore at this stage of my disease?
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
Objective response rate (ORR)
Timeframe: From baseline to progressive disease or death (approximately 1 year)
2
The number of subjects with adverse events/serious adverse events
Timeframe: Throughout the treatment and the safety follow-up period 28 [+ 7] days after the discontinuation of all study interventions, except durvalumab, nivolumab, and bevacizumab for which it will be 90 [+ 7] days (approximately 1 year)
3
PSA50 response (Substudy 3 only)
Timeframe: From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)