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New drug shows promise against multiple Hard-to-Treat cancers

NCT ID NCT04482309

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a drug called trastuzumab deruxtecan (T-DXd) in people with various advanced cancers that have a protein called HER2. The goal is to see if the drug can shrink tumors and control the disease. About 477 participants with cancers like bladder, cervical, ovarian, and pancreatic cancer will receive the drug. The study is open-label, meaning everyone knows they are getting the treatment.

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

477 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Mar 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 120 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.

Inclusion Criteria: * Locally advanced, unresectable, or metastatic disease based on most recent imaging. * Part 1:The respective cohorts for patient inclusion are: * Cohort 1: Biliary tract cancer * Cohort 2: Bladder cancer * Cohort 3: Cervical cancer * Cohort 4: Endometrial cancer * Cohort 5: Epithelial ovarian cancer * Cohort 6: Pancreatic cancer * Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. * Part 2:The respective cohorts for patient inclusion are: * Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included. * Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included. * Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+. * Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+. * Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+. * Progressed following prior treatment or who have no satisfactory alternative treatment option. * Prior HER2 targeting therapy is permitted. * HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric cancer. * Part 1: IHC 3+ or IHC 2+ by local or central assessment * Part 2: IHC and ISH results by central assessment as pre-defined for each cohort * Has measurable target disease assessed by the Investigator based on RECIST version 1.1. * Has protocol- defined adequate organ function including cardiac, renal and hepatic function. Exclusion Criteria: * History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening * Lung-specific intercurrent clinically significant severe illnesses * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals * Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART * Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. * Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer for Part 1. For Part 2, patients with primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction will be excluded. * Medical conditions that may interfere with the subject's participation in the study.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer bladder transitional cell carcinoma cervical cancer colorectal neoplasm endometrial cancer malignant pancreatic neoplasm neoplasm ovarian cancer pancreatic neoplasm urinary bladder carcinoma

As listed by the trial registrant

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

Part 1: bladder, biliary tract, cervical, endometrial, ovarian, pancreatic cancer, rare tumors, any tumor type excluding breast, gastric, colorectal cancer Part 2: HER2 expressing/amplified solid tumors excluding breast, gastric, colorectal cancer

Contacts and locations

Locations

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    Santa Rosa, California, 95403, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Muncie, Indiana, 47303, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Middletown, New Jersey, 07748, United States

  • Research Site

    Harrison, New York, 10604, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Durham, North Carolina, 27710, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Seattle, Washington, 98195, United States

  • Research Site

    Auchenflower, 4066, Australia

  • Research Site

    Blacktown, 2148, Australia

  • Research Site

    Camperdown, 2050, Australia

  • Research Site

    Heidelberg, 3084, Australia

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Brussels, 1090, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Porto Alegre, 90035-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    Vitória, 29043-272, Brazil

  • Research Site

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Research Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    Montreal, H3T 1E2, Canada

  • Research Site

    Brno, 656 53, Czechia

  • Research Site

    Hradec Králové, 500 05, Czechia

  • Research Site

    Olomouc, 77900, Czechia

  • Research Site

    Prague, 150 06, Czechia

  • Research Site

    Prague, 180 81, Czechia

  • Research Site

    Delhi, 110085, India

  • Research Site

    Gurgaon, 122001, India

  • Research Site

    Kolkata, 700160, India

  • Research Site

    Mumbai, 400012, India

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Rome, 168, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Amsterdam, 1066CX, Netherlands

  • Research Site

    Delft, 2625 AD, Netherlands

  • Research Site

    Groningen, 9700, Netherlands

  • Research Site

    Bydgoszcz, 85-796, Poland

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Krakow, 31-501, Poland

  • Research Site

    Poznan, 60-355, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Kaluga, 248007, Russia

  • Research Site

    Moscow, 115419, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 117997, Russia

  • Research Site

    Moscow, 121205, Russia

  • Research Site

    Moscow, 143423, Russia

  • Research Site

    Moscow, 143442, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 5505, South Korea

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Madrid, 28027, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Valencia, 46014, Spain

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 736, Taiwan

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10210, Thailand

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Muang, 50200, Thailand

  • Research Site

    Ongkharak, 26120, Thailand

  • Research Site

    London, SW2 6JJ, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Sutton, SM2 5PT, United Kingdom

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