NCT05489211 · AstraZeneca
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
What this study is about
TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as treatment given alone and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.
View original scientific description
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.
Interventions
DRUG
Datopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
DRUG
Capecitabine
Administered orally
DRUG
5-Fluorouracil
Administered as an IV
DRUG
Volrustomig
Administered as an IV
DRUG
Carboplatin
Administered as an IV
DRUG
Bevacizumab
Administered as an IV
DRUG
Rilvegostomig
Administered as an IV
DRUG
Prednisone/ prednisolone
Administered orally
DRUG
Cisplatin
Administered as an IV
Primary outcome measures
Objective response rate (ORR)
Time frame: From baseline to progressive disease or death (approximately 1 year)
Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1.
The number of subjects with adverse events/serious adverse events
Time frame: 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)
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
PSA50 response (Substudy 3 only)
Time frame: From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)
Proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.
Progression free survival (PFS) response (Substudy 4C only)
Time frame: From baseline to progressive disease or death (approximately 1 year)
PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Fema
Where
- Los Angeles, California
- San Diego, California
- Santa Rosa, California
- Muncie, Indiana
- Kansas City, Kansas
- Boston, Massachusetts
- Grand Rapids, Michigan
- East Brunswick, New Jersey
- Albuquerque, New Mexico
- Commack, New York
- Cincinnati, Ohio
- Columbus, Ohio
And 4 more locations — see the full list below.
Collaborators
Daiichi Sankyo
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations