At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Datopotamab deruxtecan (Dato-DXd) (drug), Capecitabine (drug), 5-Fluorouracil (drug), Volrustomig (drug)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- Datopotamab deruxtecan (Dato-DXd) — drug: Intravenous (IV) Antibody drug conjugate · Capecitabine — drug: Administered orally · 5-Fluorouracil — drug: Administered as an IV · Volrustomig — drug: Administered as an IV · Carboplatin — drug: Administered as an IV · Bevacizumab — drug: Administered as an IV · Rilvegostomig — drug: Administered as an IV · Prednisone/ prednisolone — drug: Administered orally · Cisplatin — drug: Administered as an IV
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 130 Years
- Who
- All
- Number of participants
- 454
- Started
- 2022-09-06
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for endometrial cancer
- • Phase2 - 454 participants
- • 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 take part?
- • Ages 18 Years to 130 Years
- • Diagnosed with endometrial cancer
Where?
- • Cambridge - Research Site
- • Dundee - Research Site
- • London - Research Site
- • London - Research Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types. This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), colorectal cancer (CRC) (Substudy 5), urothelial cancer (Substudy 6), and biliary tract cancer (Substudy 7) in the advanced or metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated (for all substudies except Substudy 1 and Substudy 7).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 130 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum pregnancy test documented during screening
What the study is looking for
- ✓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 that has spread cancer
- ✓activity scale performance status of 0 or 1 with no deterioration over the 2 weeks prior to...
- ✓All participants must provide a tumour sample for tissue-based analysis
Who cannot take part
- ✗Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to...
- ✗History of another primary cancer except for adequately resected basal cell carcinoma or in situ squamous cell...
- ✗Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved
- ✗Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the...
- ✗Spinal cord compression or brain metastases unless treated
See the full criteria
Where Is This Study? (6 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
London NW1 2PG, United Kingdom
Research Site
London SE1 9RT, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
