Actively Recruiting
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
Led by Daiichi Sankyo · Updated on 2025-10-14
200
Participants Needed
48
Research Sites
142 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of consent
- At least one lesion not previously irradiated and suitable for biopsy, with consent to provide a pre-treatment biopsy
- At least one measurable lesion per RECIST version 1.1 assessed by investigator
- Disease progression after the most recent systemic therapy
- Eastern Cooperative Oncology Group performance status of 0 or 1
- For endometrial cancer: documented carcinoma or carcinosarcoma, progressed after 1 to 3 prior therapies including platinum-based chemotherapy and anti-PD-1 therapy
- For cervical cancer: documented recurrent or persistent cervical carcinoma, progressed after at least one prior systemic therapy
- For non-high-grade serous ovarian cancer: documented unresectable or metastatic cancer previously treated with at least one therapy
- For urothelial cancer: documented unresectable or metastatic urothelial carcinoma, relapsed or progressed after at least one prior anti-PD-(L)1 therapy
- For clear cell renal cell carcinoma (ccRCC): documented unresectable or metastatic ccRCC, previously treated with up to 3 systemic regimens including PD-(L)1 inhibitor and VEGF-TKI
You will not qualify if you...
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
- Stroke, transient ischemic attack, or arterial thromboembolic event within 6 months before enrollment
- Uncontrolled or significant cardiovascular disease
- History of noninfectious interstitial lung disease (ILD)/pneumonitis requiring corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by imaging
- Severe pulmonary compromise
- Chronic steroid treatment over 10 mg/day (with some exceptions)
- History of other active cancers within 3 years, except those with very low risk of metastasis or death
- Unresolved toxicities from prior anticancer treatments above Grade 1 or baseline
- Prior treatment with CDH6-targeted agents or antibody-drug conjugates containing an exatecan derivative
- Ongoing uncontrolled systemic bacterial, fungal, or viral infections
- Active or uncontrolled HIV, HBV, or HCV infection
AI-Screening
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Trial Site Locations
Total: 48 locations
1
Northside Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
2
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
4
Women's Cancer Care Associates
Albany, New York, United States, 12208
Actively Recruiting
5
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
7
West Cancer Center and Research Institute
Germantown, Tennessee, United States, 38138
Actively Recruiting
8
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
9
UZ Leuven Gynaec onco
Leuven, Belgium, 3000
Actively Recruiting
10
ZAS Sint-Augustinus
Wilrijk, Belgium, 2610
Actively Recruiting
11
Hunan Cancer Hospital
Changsha, China, 410013
Actively Recruiting
12
Shanghai Cancer center
Shanghai, China, 200000
Actively Recruiting
13
Herlev og Gentofte Hosp
Copenhagen, Denmark, 2100
Actively Recruiting
14
François Baclesse Center
Caen, France, 14000
Actively Recruiting
15
Centre Georges-François Leclerc
Dijon, France, 21079
Actively Recruiting
16
Centre Oscar Lambret
Lille, France, 59 000
Actively Recruiting
17
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
18
Grp Hsp Diac Croix Saint Simon
Paris, France, 75012
Actively Recruiting
19
Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie
Plérin, France, 22190
Actively Recruiting
20
Ico - Site René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
21
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
22
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
23
AO per lEmergenza Cannizzaro
Catania, Italy, 95126
Actively Recruiting
24
Irccs Ospedale San Martino
Genova, Italy, 16132
Actively Recruiting
25
IRCCS Dino Amadori - IRST
Meldola, Italy, 47014
Actively Recruiting
26
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
27
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 40121
Actively Recruiting
28
Federico II Hospital
Naples, Italy, 80131
Actively Recruiting
29
Azienda Ospedaliera S Maria
Terni, Italy, 05100
Actively Recruiting
30
Hyogo Cancer Center
Akashi, Japan, 13-70
Actively Recruiting
31
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
32
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
33
Saitama Medical University International Medical Center
Hidaka, Japan, 1397-1
Actively Recruiting
34
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
35
The Cancer Institute Hospital of Jfcr
Kōtoku, Japan
Actively Recruiting
36
Aichi Cancer Centre
Nagoya, Japan, 464-8681
Actively Recruiting
37
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Actively Recruiting
38
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
39
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
40
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
41
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
42
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
Actively Recruiting
43
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
44
Hospital de Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
45
The Clínica Universidad de Navarra Madrid
Madrid, Spain, 28027
Actively Recruiting
46
Md Anderson Cancer Centre
Madrid, Spain, 28033
Actively Recruiting
47
Hospital 12 Octubre
Madrid, Spain, 28041
Actively Recruiting
48
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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