招募中 NCT06925737

Ifinatamab Deruxtecan ( I-DXd )在转移性前列腺癌患者中的临床研究( MK-2400-001 )

前列腺癌Phase IIIIII 期IV 期

研究人员正在寻找治疗转移性去势抵抗性前列腺癌( mCRPC )的新方法。研究人员设计了一种名为ifinatamab deruxtecan (也称为I-DXd或MK-2400 )的研究药物来治疗mCRPC。本研究的目标是了解接受I-DXd治疗的人总体寿命是否比接受化疗的人更长,并且在没有癌症生长或扩散的情况下寿命更长。

适应症:Prostate Cancer、Prostatic Neoplasms

入组条件

纳入标准

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
  • Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
  • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
  • Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
  • Has recovered from adverse events (AEs) due to previous anticancer therapies

排除标准

  • Is unable to swallow tablets/capsules
  • Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
  • Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
  • Has current ILD/pneumonitis
  • Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Has uncontrolled or significant cardiovascular disease
  • Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
  • Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
  • Has a "superscan" bone scan

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。