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REJOICE-PanTumor01: A Phase II, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants with Advanced/Metastatic Solid Tumors

Cancer
Nataliya Mar
Cervix
Kidney
Other Female Genital
Other Urinary
Ovary
Urinary Bladder

Study Description

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]).

Eligibility

Participants must meet all of the following criteria to be eligible for enrollment into the trial:

  • 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.
  • Participants must have progressed radiologically on or after their most recent line of systemic therapy.

Participants who meet any of the following criteria will be disqualified from entering the trial:

  • Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
  • Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
  • Uncontrolled or significant cardiovascular disease as specified in the protocol.
  • Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Has active or uncontrolled HIV, HBV, or HCV infection.
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