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
Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC
No open prediction endpoints
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Primary Endpoints (CT.gov)
Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)
Time frame: Baseline up to 32 months
Disease Control Rate (DCR) as Assessed by the Investigator (ccRCC Cohort Only)
Time frame: Baseline up to 32 months
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (All Cohorts)
Time frame: Baseline up to 32 months
Secondary Endpoints
Progression-free Survival (PFS) as Assessed by the Investigator
Duration of Response (DoR) as Assessed by the Investigator
Time to Response (TTR) as Assessed by the Investigator
Eligibility Criteria
Participants must meet all of the following criteria to be eligible for enrollment into the trial: 1. Adults ≥18 years of age on the day of signing the ICF. 2. Participants must have at least 1 lesion, not previously irradiated, 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. Additional inclusion criteria for endometrial cancer cohort 1. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status. 2. Documented disease progression after having received ≥1 line of therapy (no more than 3), including PBC-containing systemic treatment and an …
Read full criteria on CT.gov →✦ Analyst Commentary
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