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Pancreatic CancerOpen to EnrollmentPhase 2

ADVANCED SOLID TUMORS: GYN tumors, GU tumors: REJOICE-Pantumor01: DS6000-126

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

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Study snapshot

Title
Daiichi Sanyo DS600-126 Pan Tumor GYN/GU
Malignancy
Endometrial, Uterine, Cervical, Ovarian, Urothelial, Bladder, Renal cell carcinoma
Stage
Stage 4
Disease setting
Metastatic/Palliative
Line of therapy
At least 2nd line
Investigational agent
Raludotatug Deruxtecan
Drug class
Cadherin-6 directed ADC
Principal investigator
Michael Ulm, MD
Sponsor
Daiichi Sankyo
Path
For ovarian, non-HGSOC, for renal cell- clear cell
Randomized
No
ClinicalTrials.gov ID
NCT06660654

Eligibility and objectives

Key eligibility criteria details

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

  • Adults ≥18 years of age on the day of signing the ICF.
  • 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.
  • Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.
  • Participants must have progressed radiologically on or after their most recent line of systemic therapy.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.

  • 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 anti-PD-1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting.

  • Additional inclusion criteria for cervical cancer cohort

    1. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
    2. Disease progression after having received ≥1 prior line of therapy that includes systemic therapy in the advanced or metastatic setting.

  • Additional inclusion criterion for non-HGSOC cohort

    a. Pathologically or cytologically documented unresectable or metastatic CCOC, low grade endometrioid, low-grade serous, or mucinous OVC that was previously treated with at least 1 prior line of therapy.

  • Additional inclusion criteria for urothelial cancer cohort

    1. Pathologically or cytologically documented unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant.
    2. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting.
  • Additional inclusion criterion for the ccRCC cohort a. Pathologically or cytologically documented unresectable or metastatic ccRCC that was previously treated with no more than 3 prior systemic regimens for locally advanced or metastatic RCC, including both a PD-(L)1 checkpoint inhibitor and a VEGF-TKI in sequence or in combination.

  • 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.
  • Clinically severe pulmonary compromise
  • Chronic steroid treatment (>10 mg/day) with exceptions as noted in the protocol.
  • 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.
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline.
  • Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan).
  • Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
  • Has active or uncontrolled HIV, HBV, or HCV infection.

Objective

  • Primary
    • ORR (all cohorts except ccRCC)
    • DCR (for ccRCC only)
    • AEs
  • Secondary
    • PFS
    • DoR
    • TTR
    • PK

Treatment details

ADVANCED SOLID TUMORS: GYN tumors, GU tumors: REJOICE-Pantumor01: DS6000-126 — West Cancer Center