A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
- Conditions
- Advanced Solid TumorMetastatic Solid Tumors
- Interventions
- Registration Number
- NCT06660654
- Lead Sponsor
- Daiichi Sankyo
- Brief 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 \[ccRCC\]).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Non-high-grade Serous Ovarian Cancer Raludotatug deruxtecan Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W. Urothelial Cancer Cohort Raludotatug deruxtecan Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W. Clear Cell Renal Carcinoma (ccRCC) Cohort Raludotatug deruxtecan Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W. Endometrial Cancer Cohort Raludotatug deruxtecan Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W). Cervical Cancer Cohort Raludotatug deruxtecan Participants with cervical cancer who will receive R-DXd administered intravenously Q3W.
- Primary Outcome Measures
Name Time Method Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC) Baseline up to 32 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 32 months Disease control rate (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.
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 32 months
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) as Assessed by the Investigator Baseline up to 32 months Progression-free survival (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.
Duration of Response (DoR) as Assessed by the Investigator Baseline up to 32 months Duration of response (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.
Time to Response (TTR) as Assessed by the Investigator Baseline up to 32 months Time to response (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.
Disease Control Rate (DCR) as Assessed by the Investigator (All Cohorts Except ccRCC Cohort) Baseline up to 32 months Disease control rate (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.
Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only) Baseline up to 32 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.
Pharmacokinetic Parameter Maximum Concentration (Cmax) of R-DXd 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 32 months (each cycle is 21 days) The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have a Treatment-emergent ADA Baseline up to 32 months
Trial Locations
- Locations (10)
Astera Cancer Care
🇺🇸East Brunswick, New Jersey, United States
Women's Cancer Care Associates
🇺🇸Albany, New York, United States
Clinical Research Alliance
🇺🇸Westbury, New York, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hyogo Cancer Center
🇯🇵Akashi, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, 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
🇯🇵Koto-ku, Japan