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

Active:	Yes
Cancer Type:	Bladder Cancer Cervical Cancer Kidney Cancer Ovarian Cancer Unknown Primary Ureter Cancer Urethral Cancer Uterine Cancer	NCT ID:	NCT06660654
Trial Phases:	Phase II	Protocol IDs:	DS6000-126 (primary) NCI-2025-02421 2024-513307-13-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Daiichi Sankyo Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT06660654

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]).

Objectives

This trial is designed to evaluate the efficacy and safety of R-DXd in locally advanced
or metastatic solid tumors with various CDH6 expression levels. Solid tumor types will
include gynecological cancers (endometrial cancer, cervical cancer, and non-high-grade
serous ovarian cancer) and genitourinary cancers (urothelial cancer and ccRCC).

For all cohorts except ccRCC, the primary endpoint will be objective response rate (ORR)
by investigator assessment per RECIST 1.1. For the ccRCC cohort, the primary endpoint
will be disease control rate (DCR) by investigator assessment per RECIST 1.1. All cohorts
will also have the assessment of safety and tolerability as another primary objective.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Doctors:

Louis Crain Garrot MD

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