REJOICE-PanTumor01: A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants With Advanced/Metastatic Solid Tumors

Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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.

• 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.

∙ 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.

⁃ 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:

• 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.

• 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.

• 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).

⁃ Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.

⁃ Has active or uncontrolled HIV, HBV, or HCV infection.

Locations
United States
Georgia
Northside Hospital
RECRUITING
Marietta
Michigan
University of Michigan Comprehensive Cancer Center Michigan Medicine
RECRUITING
Ann Arbor
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
New York
Women's Cancer Care Associates
RECRUITING
Albany
Memorial Sloan-Kettering Cancer Center
RECRUITING
New York
Clinical Research Alliance
RECRUITING
Westbury
Tennessee
West Cancer Center and Research Institute
RECRUITING
Germantown
Texas
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Other Locations
Belgium
UZ Leuven Gynaec onco
RECRUITING
Leuven
ZAS Sint-Augustinus
RECRUITING
Wilrijk
China
Hunan Cancer Hospital
RECRUITING
Changsha
Shanghai Cancer center
RECRUITING
Shanghai
Denmark
Herlev og Gentofte Hosp
RECRUITING
Copenhagen
France
François Baclesse Center
RECRUITING
Caen
Centre Georges-François Leclerc
RECRUITING
Dijon
Centre Oscar Lambret
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
Grp Hsp Diac Croix Saint Simon
RECRUITING
Paris
Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie
RECRUITING
Plérin
Ico - Site René Gauducheau
RECRUITING
Saint-herblain
Institut Claudius Regaud
RECRUITING
Toulouse
Gustave Roussy
RECRUITING
Villejuif
Italy
AO per lEmergenza Cannizzaro
RECRUITING
Catania
Irccs Ospedale San Martino
RECRUITING
Genova
IRCCS Dino Amadori - IRST
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS San Raffaele
RECRUITING
Milan
Federico II Hospital
RECRUITING
Naples
Azienda Ospedaliera S Maria
RECRUITING
Terni
Japan
Hyogo Cancer Center
RECRUITING
Akashi
National Cancer Center Hospital
RECRUITING
Chūōku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Saitama Medical University International Medical Center
RECRUITING
Hidaka
National Cancer Center Hospital East
RECRUITING
Kashiwa
The Cancer Institute Hospital of Jfcr
RECRUITING
Kōtoku
Aichi Cancer Centre
RECRUITING
Nagoya
Osaka International Cancer Institute
RECRUITING
Osaka
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Hospital de Sant Pau
RECRUITING
Barcelona
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Hospital 12 Octubre
RECRUITING
Madrid
Md Anderson Cancer Centre
RECRUITING
Madrid
The Clínica Universidad de Navarra Madrid
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Contact Information
Primary
Daiichi Sankyo Contact for Clinical Trial Information
CTRinfo_us@daiichisankyo.com
9089926400
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 200
Treatments
Experimental: Endometrial Cancer Cohort
Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W).
Experimental: Cervical Cancer Cohort
Participants with cervical cancer who will receive R-DXd administered intravenously Q3W.
Experimental: Non-high-grade Serous Ovarian Cancer
Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W.
Experimental: Urothelial Cancer Cohort
Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W.
Experimental: Clear Cell Renal Carcinoma (ccRCC) Cohort
Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

Similar Clinical Trials