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New drug targets Hard-to-Treat cancers in major trial

NCT ID NCT06660654

Disease control Sponsor: Daiichi Sankyo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called raludotatug deruxtecan (R-DXd) in 200 adults with advanced or spreading solid tumors, including certain ovarian, cervical, endometrial, bladder, and kidney cancers. The goal is to see if the drug can shrink tumors or stop them from growing. Participants must have tumors that have gotten worse after prior treatment. This is not a cure, but aims to control the disease.

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 200 people

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

Started

Jan 2025

Expected to finish

Sep 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 years and older

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.

Participants must meet all of the following criteria to be eligible for enrollment into the trial: 1. Adults ≥18 years of age on the day of signing the ICF. 2. Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pre-treatment biopsy from a primary and/or metastatic lesion. 3. Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment. 4. Participants must have progressed radiologically on or after their most recent line of systemic therapy. 5. Eastern Cooperative Oncology Group performance status of 0 or 1. 6. Additional inclusion criteria for endometrial cancer cohort 1. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status. 2. Documented disease progression after having received ≥1 line of therapy (no more than 3), including PBC-containing systemic treatment and an anti-PD-1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting. 7. Additional inclusion criteria for cervical cancer cohort 1. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix. 2. Disease progression after having received ≥1 prior line of therapy that includes systemic therapy in the advanced or metastatic setting. 8. Additional inclusion criterion for non-HGSOC cohort a. Pathologically or cytologically documented unresectable or metastatic CCOC, low grade endometrioid, low-grade serous, or mucinous OVC that was previously treated with at least 1 prior line of therapy. 9. Additional inclusion criteria for urothelial cancer cohort 1. Pathologically or cytologically documented unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. 2. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. 10. Additional inclusion criterion for the ccRCC cohort a. Pathologically or cytologically documented unresectable or metastatic ccRCC that was previously treated with no more than 3 prior systemic regimens for locally advanced or metastatic RCC, including both a PD-(L)1 checkpoint inhibitor and a VEGF-TKI in sequence or in combination. Participants who meet any of the following criteria will be disqualified from entering the trial: 1. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis 2. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. 3. Uncontrolled or significant cardiovascular disease as specified in the protocol. 4. Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 5. Clinically severe pulmonary compromise 6. Chronic steroid treatment (\>10 mg/day) with exceptions as noted in the protocol. 7. History of other active malignancy within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \>90%) and treated with expected curative outcome. 8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline. 9. Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan). 10. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. 11. Has active or uncontrolled HIV, HBV, or HCV infection.

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Conditions

The condition(s) this trial relates to.

cervical cancer endometrial cancer metastatic malignant neoplasm nonpapillary renal cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Advanced solid tumor Metastatic solid tumors

Contacts and locations

Locations

  • AO per lEmergenza Cannizzaro

    Catania, 95126, Italy

  • Aichi Cancer Centre

    Nagoya, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • Azienda Ospedaliera S Maria

    Terni, 05100, Italy

  • Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie

    Plérin, 22190, France

  • Centre Georges-François Leclerc

    Dijon, 21079, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59 000, France

  • Clinical Research Alliance

    Westbury, New York, 11590, United States

  • Federico II Hospital

    Naples, 80131, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 40121, Italy

  • François Baclesse Center

    Caen, 14000, France

  • Grp Hsp Diac Croix Saint Simon

    Paris, 75012, France

  • Gustave Roussy

    Villejuif, 94800, France

  • Herlev og Gentofte Hosp

    Copenhagen, 2100, Denmark

  • Hospital 12 Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario de A Coruña

    A Coruña, 15006, Spain

  • Hospital de Sant Pau

    Barcelona, 08041, Spain

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Hyogo Cancer Center

    Akashi, 13-70, Japan

  • IRCCS Dino Amadori - IRST

    Meldola, 47014, Italy

  • IRCCS San Raffaele

    Milan, 20132, Italy

  • Ico - Site René Gauducheau

    Saint-Herblain, 44805, France

  • Institut Claudius Regaud

    Toulouse, 31100, France

  • Irccs Ospedale San Martino

    Genova, 16132, Italy

  • Md Anderson Cancer Centre

    Madrid, 28033, Spain

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • Northside Hospital

    Marietta, Georgia, 30060, United States

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Saitama Medical University International Medical Center

    Hidaka, 1397-1, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shanghai Cancer center

    Shanghai, 200000, China

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, Japan

  • The Clínica Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UZ Leuven Gynaec onco

    Leuven, 3000, Belgium

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Vall d'Hebron University Hospital

    Barcelona, 08035, Spain

  • West Cancer Center and Research Institute

    Germantown, Tennessee, 38138, United States

  • Women's Cancer Care Associates

    Albany, New York, 12208, United States

  • ZAS Sint-Augustinus

    Wilrijk, 2610, Belgium

More trials for these conditions

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