A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
Condition(s) studied
Investigational drug(s) / intervention(s)
Raludotatug deruxtecan: IV administration Q3W
Study 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 \[ccRCC\]).
Eligibility
Primary outcome measure(s)
- Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC) — Baseline up to 48 months
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. - Disease Control Rate (DCR) as Assessed by the Investigator (ccRCC Cohort Only) — Baseline up to 48 months
DCR is defined as the 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. - 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 48 months
Trial sites (48)
| Facility | City | Region | Status |
|---|---|---|---|
| Northside Hospital | Marietta | Georgia | |
| University of Michigan Comprehensive Cancer Center Michigan Medicine | Ann Arbor | Michigan | |
| Astera Cancer Care | East Brunswick | New Jersey | |
| Women's Cancer Care Associates | Albany | New York | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| Clinical Research Alliance | Westbury | New York | |
| West Cancer Center and Research Institute | Germantown | Tennessee | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| UZ Leuven Gynaec onco | Leuven | Belgium | |
| ZAS Sint-Augustinus | Wilrijk | Belgium | |
| Hunan Cancer Hospital | Changsha | China | |
| Shanghai Cancer center | Shanghai | China | |
| Herlev og Gentofte Hosp | Copenhagen | Denmark | |
| François Baclesse Center | Caen | France | |
| Centre Georges-François Leclerc | Dijon | France | |
| Centre Oscar Lambret | Lille | France | |
| Centre Leon Berard | Lyon | France | |
| Grp Hsp Diac Croix Saint Simon | Paris | France | |
| Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie | Plérin | France | |
| Ico - Site René Gauducheau | Saint-Herblain | France | |
| Institut Claudius Regaud | Toulouse | France | |
| Gustave Roussy | Villejuif | France | |
| AO per lEmergenza Cannizzaro | Catania | Italy | |
| Irccs Ospedale San Martino | Genova | Italy | |
| IRCCS Dino Amadori - IRST | Meldola | Italy | |
| IRCCS San Raffaele | Milan | Italy | |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy | |
| Federico II Hospital | Naples | Italy | |
| Azienda Ospedaliera S Maria | Terni | Italy | |
| Hyogo Cancer Center | Akashi | Japan | |
| National Cancer Center Hospital | Chūōku | Japan | |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Japan | |
| Saitama Medical University International Medical Center | Hidaka | Japan | |
| National Cancer Center Hospital East | Kashiwa | Japan | |
| The Cancer Institute Hospital of Jfcr | Kōtoku | Japan | |
| Aichi Cancer Centre | Nagoya | Japan | |
| Osaka International Cancer Institute | Osaka | Japan | |
| National Cancer Center | Goyang-si | South Korea | |
| Severance Hospital | Seoul | South Korea | |
| Asan Medical Center | Seoul | South Korea |
+ 8 more sites — see the full list on the official registry below.
More Daiichi Sankyo trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06660654 on ClinicalTrials.gov ↗ ← All trials in France