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AzTrials

Endometrial CancerPhase 2NCT05489211

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Phase 2 study testing Datopotamab deruxtecan (Dato-DXd), Capecitabine and 5-Fluorouracil in people with Endometrial Cancer and Gastric Cancer, run by AstraZeneca at 96 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 130 years
What is being tested?
Datopotamab deruxtecan (Dato-DXd), Capecitabine and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
454 participants
Where
96 sitesin 14 countries
Study dates
6 Sep 2022to 1 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
  • History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent
  • 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 investigator, for example hearing loss
  • Spinal cord compression or brain metastases unless treated
  • Leptomeningeal carcinomatosis
Show all 31Show fewer
  • Clinically significant corneal disease
  • Active hepatitis or uncontrolled hepatitis B or C virus infection
  • Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms
  • Known HIV infection that is not well controlled
  • Known active tuberculosis infection
  • Mean resting corrected QTcF > 470 ms
  • In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP
  • In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives
  • Uncontrolled or significant cardiac diseases
  • History of non-infectious Interstitial lung disease (ILD)/pneumonitis, including radiation pneumonitis that required steroids
  • Has severe pulmonary function compromise
  • Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
  • Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment
  • Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention
  • Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
  • Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload
  • Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention
  • Previous treatment in the present study
  • Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study
  • Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies
  • Involvement in the planning and/or conduct of the study
  • Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
  • Females that are pregnant, breastfeeding, or planning to become pregnant
  • Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd

Trial locations and contacts

96 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

96 sites in 14 countries

United States18 sites, 11 recruiting

  • Research Site

    Albuquerque, New Mexico, 87109

    Recruiting

  • Research Site

    Boston, Massachusetts, 02114

    Withdrawn

  • Research Site

    Boston, Massachusetts, 02215

    Completed

  • Research Site

    Cincinnati, Ohio, 45219

    Recruiting

  • Research Site

    Columbus, Ohio, 43219

    Recruiting

  • Research Site

    Commack, New York, 11725

    Recruiting

  • Research Site

    East Brunswick, New Jersey, 08816

    Recruiting

  • Research Site

    Grand Rapids, Michigan, 49503

    Recruiting

  • Research Site

    Houston, Texas, 77030

    Recruiting

  • Research Site

    Kansas City, Kansas, 66160

    Withdrawn

  • Research Site

    Los Angeles, California, 90095

    Recruiting

  • Research Site

    Madison, Wisconsin, 53792

    Recruiting

  • Research Site

    Muncie, Indiana, 47303

    Withdrawn

  • Research Site

    Nashville, Tennessee, 37203

    Recruiting

  • Research Site

    Nashville, Tennessee, 37232

    Withdrawn

  • Research Site

    Portland, Oregon, 97239

    Withdrawn

  • Research Site

    San Diego, California, 92103

    Withdrawn

  • Research Site

    Santa Rosa, California, 95403

    Recruiting

Other trials in United States

China14 sites, 5 recruiting

  • Research Site

    Changsha, 410013

    Withdrawn

  • Research Site

    Chongqing, 400030

    Withdrawn

  • Research Site

    Guangzhou, 510060

    Completed

  • Research Site

    Guangzhou, 510060

    Recruiting

  • Research Site

    Guangzhou, 510120

    Withdrawn

  • Research Site

    Hangzhou, 310020

    Recruiting

  • Research Site

    Hefei, 230001

    Withdrawn

  • Research Site

    Shanghai, 200032

    Recruiting

  • Research Site

    Shanghai, 200032

    Not yet recruiting

  • Research Site

    Shenyang, 110016

    Withdrawn

  • Research Site

    Wuhan, 430030

    Withdrawn

  • Research Site

    Wuhan, 430079

    Withdrawn

  • Research Site

    Xi'an, 710000

    Withdrawn

  • Research Site

    Zhengzhou, 450052

    Recruiting

Other trials in China

Turkey (Türkiye)8 sites, 7 recruiting

  • Research Site

    Ankara, 06620

    Recruiting

  • Research Site

    Ankara, 06800

    Recruiting

  • Research Site

    Cordaleo, 35575

    Recruiting

  • Research Site

    Edirne, 22030

    Recruiting

  • Research Site

    Kadıkoy/Istanbul, 34722

    Recruiting

  • Research Site

    Konya, 42080

    Recruiting

  • Research Site

    Pamukkale, 20070

    Recruiting

  • Research Site

    Samsun, 55139

    Withdrawn

Other trials in Turkey (Türkiye)

Italy7 sites, 3 recruiting

  • Research Site

    Florence, 50139

    Withdrawn

  • Research Site

    Genova, 16132

    Withdrawn

  • Research Site

    Milan, 20132

    Recruiting

  • Research Site

    Milan, 20141

    Withdrawn

  • Research Site

    Milan, 20162

    Recruiting

  • Research Site

    Naples, 80131

    Recruiting

  • Research Site

    Rome, 00168

    Withdrawn

Other trials in Italy

Japan6 sites, 6 recruiting

  • Research Site

    Chūōku, 104-0045

    Recruiting

  • Research Site

    Kashiwa, 277-8577

    Recruiting

  • Research Site

    Kōtoku, 135-8550

    Recruiting

  • Research Site

    Nagoya, 464-8681

    Recruiting

  • Research Site

    Shinagawa-ku, 142-8666

    Recruiting

  • Research Site

    Suita-shi, 565-0871

    Recruiting

Other trials in Japan

Spain6 sites, 5 recruiting

  • Research Site

    Barcelona, 8035

    Recruiting

  • Research Site

    Córdoba, 14004

    Terminated

  • Research Site

    Madrid, 28046

    Recruiting

  • Research Site

    Málaga, 29010

    Recruiting

  • Research Site

    Pamplona, 31008

    Recruiting

  • Research Site

    Seville, 41013

    Recruiting

Other trials in Spain

United Kingdom6 sites, 6 recruiting

  • Research Site

    Cambridge, CB2 0QQ

    Recruiting

  • Research Site

    Dundee, DD1 9SY

    Recruiting

  • Research Site

    London, EC1A 7BE

    Recruiting

  • Research Site

    London, NW1 2PG

    Recruiting

  • Research Site

    London, SE1 9RT

    Recruiting

  • Research Site

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

Canada5 sites

  • Research Site

    Montreal, Quebec, H2X 0A9

    Withdrawn

  • Research Site

    Montreal, Quebec, H4A 3J1

    Completed

  • Research Site

    Québec, Quebec, G1J 1Z4

    Active, not recruiting

  • Research Site

    Toronto, Ontario, M4N 3M5

    Withdrawn

  • Research Site

    Toronto, Ontario, M5G 2M9

    Completed

Other trials in Canada

Germany5 sites

  • Research Site

    Berlin, 10117

    Withdrawn

  • Research Site

    Essen, 45136

    Withdrawn

  • Research Site

    Hanover, 30625

    Withdrawn

  • Research Site

    München, 81377

    Withdrawn

  • Research Site

    Regensburg, 93053

    Withdrawn

Other trials in Germany

Poland5 sites, 2 recruiting

  • Research Site

    Gliwice, 44-102

    Recruiting

  • Research Site

    Krakow, 31-501

    Recruiting

  • Research Site

    Lodz, 92-213

    Withdrawn

  • Research Site

    Poznan, 61-866

    Withdrawn

  • Research Site

    Warsaw, 02-781

    Completed

Other trials in Poland

Taiwan5 sites, 5 recruiting

  • Research Site

    Liou Ying Township, 736

    Recruiting

  • Research Site

    Taipei, 100

    Recruiting

  • Research Site

    Taipei, 11259

    Recruiting

  • Research Site

    Taipei, 112

    Recruiting

  • Research Site

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

France4 sites, 3 recruiting

  • Research Site

    Bordeaux, 33076

    Recruiting

  • Research Site

    Lyon, 69373

    Recruiting

  • Research Site

    Marseille, 13273

    Withdrawn

  • Research Site

    Suresnes, 92150

    Recruiting

Other trials in France

South Korea4 sites, 4 recruiting

  • Research Site

    Seoul, 03722

    Recruiting

  • Research Site

    Seoul, 05505

    Recruiting

  • Research Site

    Seoul, 06351

    Recruiting

  • Research Site

    Seoul, 110-744

    Recruiting

Other trials in South Korea

Switzerland3 sites

  • Research Site

    Basel, 4031

    Withdrawn

  • Research Site

    Bellinzona, 6500

    Withdrawn

  • Research Site

    Sankt Gallen, 9007

    Withdrawn

Other trials in Switzerland

About this study

Official title: A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

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.

Read the detailed description

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).

Being tested
Datopotamab deruxtecan (Dato-DXd), Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Keywords
TROPION-PanTumor03, Datopotamab Deruxtecan (Dato-DXd), Solid Tumours, Antibody-drug conjugate (ADC), Trophoblast cell surface protein 2 (TROP2)
Medical subject headings
Endometrial Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Datopotamab deruxtecan (Dato-DXd)Drug

    Also called DS-1062a

    Intravenous (IV) Antibody drug conjugate

  • CapecitabineDrug

    Also called Xeloda

    Administered orally

  • 5-FluorouracilDrug

    Also called Adrucil

    Administered as an IV

  • VolrustomigDrug

    Also called MEDI5752

    Administered as an IV

  • CarboplatinDrug

    Also called Paraplatin

    Administered as an IV

  • BevacizumabDrug

    Also called Avastin

    Administered as an IV

  • RilvegostomigDrug

    Also called AZD2936

    Administered as an IV

  • Prednisone/ prednisoloneDrug

    Also called Prednisolone

    Administered orally

  • CisplatinDrug

    Also called Platinol

    Administered as an IV

Study groups in NCT05489211
Study groupRoleWhat they receive
Substudy-1AExperimentalDato-DXd will be evaluated as monotherapy
Receives: Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-2AExperimentalDato-DXd in combination with capecitabine will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Capecitabine
Substudy-2BExperimentalDato-DXd in combination with 5-FU will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: 5-Fluorouracil
Substudy-3AExperimentalDato-DXd will be evaluated as monotherapy
Receives: Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-3CExperimentalDato-DXd will be evaluated in combination with prednisone/prednisolone
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Prednisone/ prednisolone
Substudy-4AExperimentalDato-DXd will be evaluated as monotherapy
Receives: Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-4CExperimentalDato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Carboplatin; Drug: Bevacizumab
Substudy-5AExperimentalDato-DXd will be evaluated as monotherapy
Receives: Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-6AExperimentalDato-DXd in combination with volrustomig (MEDI5752) will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Volrustomig
Substudy-6BExperimentalData-DXd in combination with rilvegostomig (AZD2936) will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Rilvegostomig
Substudy-6CExperimentalDato-DXd will be evaluated as monotherapy
Receives: Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-6DExperimentalDato-DXd in combination with carboplatin or cisplatin will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Carboplatin; Drug: Cisplatin
Substudy-6EExperimentalDato-DXd in combination with rilvegostomig (AZD2936) will be evaluated
Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Rilvegostomig
Substudy-7AExperimentalDato-DXd will be evaluated as monotherapy
Receives: Drug: Datopotamab deruxtecan (Dato-DXd)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1.

    Measured: From baseline to progressive disease or death (approximately 1 year)

  2. The number of subjects with adverse events/serious adverse events

    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.

    Measured: 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)

    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.

    Measured: From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)

  4. Progression free survival (PFS) response (Substudy 4C only)

    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.

    Measured: From baseline to progressive disease or death (approximately 1 year)

Secondary outcomes (14)

  1. Progression free survival (PFS)

    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.

    Measured: From baseline to progressive disease or death (approximately 1 year)

  2. Duration Of Response (DoR)

    DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause.

    Measured: From baseline to progressive disease or death (approximately 1 year)

  3. Disease Control Rate (DCR)

    DCR at 12 and 24 weeks is defined as the percentage of participants who prior to Progression of Disease (PD) and starting anticancer therapy have either at least one visit response of Complete response (CR)/Partial response (PR) or Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.

    Measured: At approximately 1 year

  4. Best percentage change in tumour size

    The best percentage change from baseline in tumour size will be derived as the maximum reduction from baseline or (in the absence of reduction) the minimum increase from baseline.

    Measured: From baseline to progressive disease or death (approximately 1 year)

  5. Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Maximum plasma concentration of the drug (Cmax)

    The concentration in plasma will be determined.

    Measured: At predefined intervals throughout the treatment period (approximately 1 year)

  6. Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): The time taken to reach the maximum concentration (Tmax)

    The concentration in plasma will be determined.

    Measured: At predefined intervals throughout the treatment period (approximately 1 year)

  7. Pharmacokinetic Parameter of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Area under the plasma concentration- time curve (AUC)

    The concentration in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

    Measured: At predefined intervals throughout the treatment period (approximately 1 year)

  8. Plasma concentration of Total anti-TROP2 antibody

    Expression of TROP2 will be measured in blood sample

    Measured: Throughout the treatment period at pre-defined intervals (approximately 1 year)

  9. Plasma concentration of MAAA-1181a

    The concentration in plasma will be determined (Cmax will be derived).

    Measured: Throughout the treatment period at pre-defined intervals (approximately 1 year)

  10. Anti Drug Antibody (ADA) for Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6)

    Whole blood samples for determination of ADA in plasma will be collected; Percentage of patients who develop ADA

    Measured: Throughout the treatment period at pre-defined intervals and including the safety follow-up period (approximately 1 year)

  11. Radiographic PFS (Substudy 3)

    PFS is defined as time from start of treatment until radiographic progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as assessed by the investigator or death due to any cause.

    Measured: From baseline to radiographic progression or death (approximately 1 year)

  12. PSA progression (Substudy 3)

    PSA progression is defined as an increase in PSA (after Week 12) of ≥25% greater than the nadir and an absolute increase of at least 2 ng/mL above nadir.

    Measured: From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)

  13. CA-125 response (Substudy 4)

    Proportion of participants achieving a > 50% reduction in CA-125 levels from a pre-treatment sample confirmed and maintained for at least 28 days.

    Measured: From baseline to CA-125 response evaluated according to the GCIG criteria (approximately 1 year)

  14. Overall survival (OS) (Substudy 4)

    OS is defined as time from start of treatment until death due to any cause.

    Measured: From baseline to death (approximately 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start6 Sep 2022
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Within each substudy, Dato-DXd will be evaluated as monotherapy (all except #2 Gastric Cancer) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated (all except #1 Endometrial Cancer and #7 Biliary Tract Cancer). All substudies will be treatment assigned. Substudy 1 (Endometrial): MONO: Dato-DXd Substudy 2 (Gastric): COMBO: Dato-DXd + capecitabine, Dato-DXd + 5-fluorouracil (5-FU) Substudy 3 (mCRPC): MONO: Dato-DXd; COMBO: Dato-DXd + prednisone/prednisolone Substudy 4 (Ovarian): MONO: Dato-DXd; COMBO: Dato-DXd + carboplatin + bevacizumab --\> Dato-DXd + bevacizumab Substudy 5 (CRC): MONO: Dato-DXd; COMBO: Dato-DXd + 5-FU + leucovorin + bevacizumab or Dato-DXd + capecitabine + bevacizumab Substudy 6 (Urothelial): MONO: Dato-DXd; COMBO: Dato-DXd + volrustomig, Dato-DXd + rilvegostomig, Dato-DXd + carboplatin or cisplatin Substudy 7 (BTC): MONO: Dato-DXd
Masking
None (open label)
Enrolment
454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489211
Sponsor's protocol ID
D926UC00001
Other IDs
2023-509436-26-00, 2022-000776-19, 2023
Status last verified
Sep 2026
First submitted
21 Jul 2022
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Datopotamab deruxtecan (Dato-DXd), Capecitabine and 5-Fluorouracil in people with Endometrial Cancer and Gastric Cancer, run by AstraZeneca at 96 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, China, Turkey (Türkiye), Italy, Japan and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: From baseline to progressive disease or death (approximately 1 year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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