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

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
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06660654
Enrollment
335
Registered
2024-10-28
Start date
2025-01-06
Completion date
2029-12-30
Last updated
2026-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor, Metastatic Solid Tumors

Keywords

Advanced/metastatic solid tumors, Raludotatug Deruxtecan, R-DXd, DS-6000

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.

Interventions

IV administration Q3W

Sponsors

Daiichi Sankyo
Lead SponsorINDUSTRY
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)Baseline up to 48 monthsObjective 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 monthsDCR 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—

Secondary

MeasureTime frameDescription
Progression-free Survival (PFS) as Assessed by the InvestigatorBaseline up to 48 monthsPFS 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 InvestigatorBaseline up to 48 monthsDoR 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 InvestigatorBaseline up to 48 monthsTTR 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.
Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only)Baseline up to 48 monthsORR is defined as the proportion of participants with a BOR of confirmed CR or PR according to RECIST version 1.1 criteria.
Disease Control Rate (DCR) as Assessed by the Investigator (All Cohorts Except ccRCC Cohort)Baseline up to 48 monthsDCR 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.
Pharmacokinetic Parameter Maximum Concentration (Cmax) of R-DXdCycles 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)—
The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have a Treatment-emergent ADABaseline up to 48 months—

Countries

Belgium, China, Denmark, France, Italy, Japan, South Korea, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 25, 2026