Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug cocktail takes on seven tough cancers

NCT ID NCT05489211

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This phase 2 trial is testing a drug called datopotamab deruxtecan (Dato-DXd), alone or with other cancer medicines, in people with advanced or metastatic solid tumours. The study includes seven cancer types and aims to see if the drug shrinks tumours and how safe it is. Around 454 participants will be enrolled at multiple centres.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
datopotamab deruxtecan (Dato-DXd), a targeted chemotherapy drug
What this could lead to
If successful, this could offer a new treatment option for several advanced cancers that are hard to treat.
What could go wrong
This is an early-phase trial with many different cancer types, so results may not apply to all. Side effects from the drug combinations could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 454 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 giving signed informed consent * Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative Key Exclusion Criteria: * 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 * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Biliary tract cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms castration-resistant prostate carcinoma colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm gastric cancer gastric neoplasm metastatic prostate carcinoma ovarian cancer urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer Colorectal cancer Endometrial cancer Gastric cancer Metastatic castration resistant prostate cancer Ovarian cancer Urothelial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    57 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

    WITHDRAWN

    San Diego, California, 92103, United States

  • Research Site

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Research Site

    WITHDRAWN

    Muncie, Indiana, 47303, United States

  • Research Site

    WITHDRAWN

    Kansas City, Kansas, 66160, United States

  • Research Site

    WITHDRAWN

    Boston, Massachusetts, 02114, United States

  • Research Site

    COMPLETED

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Research Site

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Research Site

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Research Site

    RECRUITING

    Commack, New York, 11725, United States

  • Research Site

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Research Site

    RECRUITING

    Columbus, Ohio, 43219, United States

  • Research Site

    WITHDRAWN

    Portland, Oregon, 97239, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    WITHDRAWN

    Nashville, Tennessee, 37232, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Research Site

    WITHDRAWN

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    COMPLETED

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    WITHDRAWN

    Montreal, Quebec, H2X 0A9, Canada

  • Research Site

    COMPLETED

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    ACTIVE_NOT_RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    WITHDRAWN

    Changsha, 410013, China

  • Research Site

    WITHDRAWN

    Chongqing, 400030, China

  • Research Site

    COMPLETED

    Guangzhou, 510060, China

  • Research Site

    RECRUITING

    Guangzhou, 510060, China

  • Research Site

    WITHDRAWN

    Guangzhou, 510120, China

  • Research Site

    RECRUITING

    Hangzhou, 310020, China

  • Research Site

    WITHDRAWN

    Hefei, 230001, China

  • Research Site

    RECRUITING

    Shanghai, 200032, China

  • Research Site

    NOT_YET_RECRUITING

    Shanghai, 200032, China

  • Research Site

    WITHDRAWN

    Shenyang, 110016, China

  • Research Site

    WITHDRAWN

    Wuhan, 430030, China

  • Research Site

    WITHDRAWN

    Wuhan, 430079, China

  • Research Site

    WITHDRAWN

    Xi'an, 710000, China

  • Research Site

    RECRUITING

    Zhengzhou, 450052, China

  • Research Site

    RECRUITING

    Bordeaux, 33076, France

  • Research Site

    RECRUITING

    Lyon, 69373, France

  • Research Site

    WITHDRAWN

    Marseille, 13273, France

  • Research Site

    RECRUITING

    Suresnes, 92150, France

  • Research Site

    WITHDRAWN

    Berlin, 10117, Germany

  • Research Site

    WITHDRAWN

    Essen, 45136, Germany

  • Research Site

    WITHDRAWN

    Hanover, 30625, Germany

  • Research Site

    WITHDRAWN

    München, 81377, Germany

  • Research Site

    WITHDRAWN

    Regensburg, 93053, Germany

  • Research Site

    WITHDRAWN

    Florence, 50139, Italy

  • Research Site

    WITHDRAWN

    Genova, 16132, Italy

  • Research Site

    RECRUITING

    Milan, 20132, Italy

  • Research Site

    WITHDRAWN

    Milan, 20141, Italy

  • Research Site

    RECRUITING

    Milan, 20162, Italy

  • Research Site

    RECRUITING

    Naples, 80131, Italy

  • Research Site

    WITHDRAWN

    Rome, 00168, Italy

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Nagoya, 464-8681, Japan

  • Research Site

    RECRUITING

    Shinagawa-ku, 142-8666, Japan

  • Research Site

    RECRUITING

    Suita-shi, 565-0871, Japan

  • Research Site

    RECRUITING

    Gliwice, 44-102, Poland

  • Research Site

    RECRUITING

    Krakow, 31-501, Poland

  • Research Site

    WITHDRAWN

    Lodz, 92-213, Poland

  • Research Site

    WITHDRAWN

    Poznan, 61-866, Poland

  • Research Site

    COMPLETED

    Warsaw, 02-781, Poland

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 110-744, South Korea

  • Research Site

    RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    TERMINATED

    Córdoba, 14004, Spain

  • Research Site

    RECRUITING

    Madrid, 28046, Spain

  • Research Site

    RECRUITING

    Málaga, 29010, Spain

  • Research Site

    RECRUITING

    Pamplona, 31008, Spain

  • Research Site

    RECRUITING

    Seville, 41013, Spain

  • Research Site

    WITHDRAWN

    Basel, 4031, Switzerland

  • Research Site

    WITHDRAWN

    Bellinzona, 6500, Switzerland

  • Research Site

    WITHDRAWN

    Sankt Gallen, 9007, Switzerland

  • Research Site

    RECRUITING

    Liou Ying Township, 736, Taiwan

  • Research Site

    RECRUITING

    Taipei, 100, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11259, Taiwan

  • Research Site

    RECRUITING

    Taipei, 112, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Cordaleo, 35575, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Kadıkoy/Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Konya, 42080, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Pamukkale, 20070, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Samsun, 55139, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Research Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Research Site

    RECRUITING

    London, NW1 2PG, United Kingdom

  • Research Site

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.