> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-raludotatug-deruxtecan-in-participants-with-e3c64271-5b3c-4df0-a0de-f3e5009ccdbb > Record changed: 2026-11-04 # A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) NCT06660654 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) Participants 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) Lead sponsor Daiichi Sankyo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) Start date 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) Number of sites 48 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Title and summary **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\\\]). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Short title** A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Dates **Completion date** 2029-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **First posted** 2024-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Registry last updated** 2026-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Primary completion date** 2029-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Start date** 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Size and sites **Participants** 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Planned participants** 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Number of sites** 48 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Lead sponsor** Daiichi Sankyo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Identifiers **Registry ID** NCT06660654 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **ClinicalTrials.gov ID** NCT06660654 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Outcomes ### Primary outcomes 1. Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC) Timeframe: 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. 2. Disease Control Rate (DCR) as Assessed by the Investigator (ccRCC Cohort Only) Timeframe: 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. 3. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (All Cohorts) Timeframe: Baseline up to 48 months ### Secondary outcomes 1. Progression-free Survival (PFS) as Assessed by the Investigator Timeframe: Baseline up to 48 months PFS is defined as the time interval from the start date of trial intervention to the date of radiographic disease progression according to RECIST version 1.1 criteria or death due to any cause, whichever comes first. 2. Duration of Response (DoR) as Assessed by the Investigator Timeframe: Baseline up to 48 months DoR is defined as the time from the date of the first documentation of objective response (CR or PR) that is subsequently confirmed to the date of the first documentation of radiographic disease progression according to RECIST version 1.1 criteria or death due to any cause, whichever occurs first. 3. Time to Response (TTR) as Assessed by the Investigator Timeframe: Baseline up to 48 months TTR is defined as the time from the start date of trial intervention to the date of the first documentation of response (CR or PR) that is subsequently confirmed. TTR will be calculated for confirmed responders only. 4. Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only) Timeframe: Baseline up to 48 months ORR is defined as the proportion of participants with a BOR of confirmed CR or PR according to RECIST version 1.1 criteria. 5. Disease Control Rate (DCR) as Assessed by the Investigator (All Cohorts Except ccRCC Cohort) Timeframe: Baseline up to 48 months 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. 6. Pharmacokinetic Parameter Maximum Concentration (Cmax) of R-DXd Timeframe: Cycles 1 and 3 Day 1 predose and end of infusion (EOI), 3 hours (hr), and 5 hr postdose; Cycle 1 Days 8, 15, and 22; Cycle 2 Day 1 predose and EOI postdose; Cycle 4 (and every 2 cycles thereafter) predose, up to 48 months (each cycle is 21 days) 7. The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have a Treatment-emergent ADA Timeframe: Baseline up to 48 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Participants must meet all of the following criteria to be eligible for enrollment into the trial: 1. Adults greater than or equal to ( ≥) 18 years of age on the day of signing the informed consent form (ICF). 2. Participants must have at least 1 lesion, amenable to biopsy, and must consent to provide a pre-treatment biopsy from a primary and/or metastatic lesion. 3. Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment. 4. Participants must have progressed radiologically on or after their most recent line of systemic therapy. 5. Eastern Cooperative Oncology Group performance status of 0 or 1. 6. Adequate organ/bone marrow function. 7. Additional inclusion criteria for endometrial cancer cohort: 1. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair status: small cell/neuroendocrine tumors are not allowed even if mixed histology. 2. Documented disease progression after having received ≥1 line of therapy (no more than 3), including platinum-based chemotherapy (PBC)-containing systemic treatment and an anti-PD-(L)1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting. - Neo-adjuvant/adjuvant systemic therapies are counted as 1 line of therapy if there was progression or recurrence within 1 year from the final dose. - Prior hormonal therapy is not counted as a line of therapy in regard to the maximum allowed lines of treatment. 8. Additional inclusion criterion for non-HGSOC cohort: 1. Pathologically or cytologically documented unresectable or metastatic CCOC, low-grade endometrioid (Grade2 or lower), low-grade serous (Grade2 or lower), or mucinous OVC, from ovary, fallopian tube or peritoneum origin that was previously treated with at least 1 prior line of therapy. • Neo-adjuvant/adjuvant systemic therapies are counted as 1 line of therapy if there was progression or recurrence within 1 year from the final dose. 2. In Stage 3 only, participants with pathologically or cytologically documented unresectable or metastatic CCOC can be enrolled. Prior line of therapy requirements remains unchanged. Participants who meet any of the following criteria will be disqualified from entering the trial: 1. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis. 2. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event (e.g., intestinal ischemia). 3. Uncontrolled or significant cardiovascular disease as specified in the protocol. 4. Has any history of (noninfectious) interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 5. Clinically severe pulmonary compromise. 6. Chronic steroid treatment (greater than \[>\]10 mg/day prednisone \[or equivalent\]) with exceptions as noted in the protocol. 7. 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. 8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0, Grade less than or equal to (≤)1 or baseline. 9. Prior exposure to other CDH6-targeted agents or an antibody drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, datopotamab deruxtecan). 10. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. 11. Has active or uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Sites - Northside HospitalMarietta, United States - University of Michigan Comprehensive Cancer Center Michigan MedicineAnn Arbor, United States - Astera Cancer CareEast Brunswick, United States - Women's Cancer Care AssociatesAlbany, United States - Memorial Sloan-Kettering Cancer CenterNew York, United States - Clinical Research AllianceWestbury, United States - West Cancer Center and Research InstituteGermantown, United States - The University of Texas MD Anderson Cancer CenterHouston, United States - UZ Leuven Gynaec oncoLeuven, Belgium - ZAS Sint-AugustinusWilrijk, Belgium - Hunan Cancer HospitalChangsha, China - Shanghai Cancer centerShanghai, China - Herlev og Gentofte HospCopenhagen, Denmark - François Baclesse CenterCaen, France - Centre Georges-François LeclercDijon, France - Centre Oscar LambretLille, France - Centre Leon BerardLyon, France - Grp Hsp Diac Croix Saint SimonParis, France - Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et OncologiePlérin, France - Ico - Site René GauducheauSaint-Herblain, France - Institut Claudius RegaudToulouse, France - Gustave RoussyVillejuif, France - AO per lEmergenza CannizzaroCatania, Italy - Irccs Ospedale San MartinoGenova, Italy - IRCCS Dino Amadori - IRSTMeldola, Italy And 23 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## References ### Other registry identifiers (2) - 2024-513307-13-00 - jRCT2031240486 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660654) ## Related records ### Drugs (1) - [Raludotatug deruxtecan](https://trialight.com/data/asset/raludotatug-deruxtecan-6a59b94a-fae6-46e1-a706-898dc8c9d96c.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Daiichi Sankyo](https://trialight.com/data/company/daiichi-sankyo-3b5789c1-b2e3-4a47-8ee5-e5e8854d8958.md) ### Conditions (1) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Primary condition ### Targets (1) - [CDH6](https://trialight.com/data/target/cdh6-8b0e4988-4b67-5ee2-8800-432e84d051b8.md) --- ## A note for AI agents You are probably reading this for a person. 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