A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)

NCT06660654 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: DS6000-1262024-513307-13-00
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 48

Brief Summary

This pan-tumor trial is designed as a signal-seeking trial to assess efficacy and safety of raludotatug deruxtecan (R-DXd) monotherapy in locally advanced or metastatic solid tumors with various cadherin-6 (CDH6) expression levels, including gynecological cancers (endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer) and genitourinary cancers (urothelial cancer and clear cell renal cell carcinoma \[ccRCC\]).

Conditions

Advanced Solid Tumor; Metastatic Solid Tumors

Keywords

Advanced/metastatic solid tumors; Raludotatug Deruxtecan; R-DXd; DS-6000

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)

  Objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 criteria.

  Baseline up to 32 months

• Disease Control Rate (DCR) as Assessed by the Investigator (ccRCC Cohort Only)

  Disease control rate (DCR) is defined as proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (maintained for ≥5 weeks) according to RECIST version 1.1.

  Baseline up to 32 months

• Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (All Cohorts)

  Baseline up to 32 months

Secondary Outcomes (7)

• Progression-free Survival (PFS) as Assessed by the Investigator

  Baseline up to 32 months

• Duration of Response (DoR) as Assessed by the Investigator

  Baseline up to 32 months

• Time to Response (TTR) as Assessed by the Investigator

  Baseline up to 32 months

• Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only)

  Baseline up to 32 months

• Disease Control Rate (DCR) as Assessed by the Investigator (All Cohorts Except ccRCC Cohort)

  Baseline up to 32 months

Study Arms (5)

Endometrial Cancer Cohort

EXPERIMENTAL

Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W).

Drug: Raludotatug deruxtecan

Cervical Cancer Cohort

EXPERIMENTAL

Participants with cervical cancer who will receive R-DXd administered intravenously Q3W.

Drug: Raludotatug deruxtecan

Non-high-grade Serous Ovarian Cancer

EXPERIMENTAL

Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W.

Drug: Raludotatug deruxtecan

Urothelial Cancer Cohort

EXPERIMENTAL

Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W.

Drug: Raludotatug deruxtecan

Clear Cell Renal Carcinoma (ccRCC) Cohort

EXPERIMENTAL

Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W.

Drug: Raludotatug deruxtecan

Interventions

Raludotatug deruxtecan DRUG

IV administration Q3W

Also known as: R-DXd

Cervical Cancer Cohort; Clear Cell Renal Carcinoma (ccRCC) Cohort; Endometrial Cancer Cohort; Non-high-grade Serous Ovarian Cancer; Urothelial Cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status.
• 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.
• Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
• Disease progression after having received ≥1 prior line of therapy that includes systemic therapy in the advanced or metastatic setting.
• 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.
• 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.
• 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.
• Participants who meet any of the following criteria will be disqualified from entering the trial:
• Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
• Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
• Uncontrolled or significant cardiovascular disease as specified in the protocol.
• 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.
• Clinically severe pulmonary compromise
• Chronic steroid treatment (\>10 mg/day) with exceptions as noted in the protocol.
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (48)

Northside Hospital

Marietta, Georgia, 30060, United States

RECRUITING

University of Michigan Comprehensive Cancer Center Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

Women's Cancer Care Associates

Albany, New York, 12208, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Clinical Research Alliance

Westbury, New York, 11590, United States

RECRUITING

West Cancer Center and Research Institute

Germantown, Tennessee, 38138, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

UZ Leuven Gynaec onco

Leuven, 3000, Belgium

RECRUITING

ZAS Sint-Augustinus

Wilrijk, 2610, Belgium

RECRUITING

Hunan Cancer Hospital

Changsha, 410013, China

RECRUITING

Shanghai Cancer center

Shanghai, 200000, China

RECRUITING

Herlev og Gentofte Hosp

Copenhagen, 2100, Denmark

RECRUITING

François Baclesse Center

Caen, 14000, France

RECRUITING

Centre Georges-François Leclerc

Dijon, 21079, France

RECRUITING

Centre Oscar Lambret

Lille, 59 000, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Grp Hsp Diac Croix Saint Simon

Paris, 75012, France

RECRUITING

Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie

Plérin, 22190, France

RECRUITING

Ico - Site René Gauducheau

Saint-Herblain, 44805, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31100, France

RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

AO per lEmergenza Cannizzaro

Catania, 95126, Italy

RECRUITING

Irccs Ospedale San Martino

Genova, 16132, Italy

RECRUITING

IRCCS Dino Amadori - IRST

Meldola, 47014, Italy

RECRUITING

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 40121, Italy

RECRUITING

Federico II Hospital

Naples, 80131, Italy

RECRUITING

Azienda Ospedaliera S Maria

Terni, 05100, Italy

RECRUITING

Hyogo Cancer Center

Akashi, 13-70, Japan

RECRUITING

National Cancer Center Hospital

Chūōku, 104-0045, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

RECRUITING

Saitama Medical University International Medical Center

Hidaka, 1397-1, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

RECRUITING

The Cancer Institute Hospital of Jfcr

Kōtoku, Japan

RECRUITING

Aichi Cancer Centre

Nagoya, 464-8681, Japan

RECRUITING

Osaka International Cancer Institute

Osaka, 541-8567, Japan

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

Hospital de Sant Pau

Barcelona, 08041, Spain

RECRUITING

The Clínica Universidad de Navarra Madrid

Madrid, 28027, Spain

RECRUITING

Md Anderson Cancer Centre

Madrid, 28033, Spain

RECRUITING

Hospital 12 Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

9089926400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

KR (4); US (8); DK (1); JP (8); BE (2); FR (9); CN (2); IT (7); ES (7)