CTIS2022-501078-20-00招募中1 期
A Phase 2, Randomized, Open-Label Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants with Metastatic Castration-Resistant Prostate Cancer (TAMARACK) - CP-MGC018-03
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features, Participants must have = 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained = 28 days prior to initiation of study treatment, Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria, Received 1 prior ARAT for metastatic or non-metastatic, castrationsensitive or castration-resistant prostate cancer. A second ARAT regimen of < 60 days used as bridging to lutetium-177 is permitted., Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs, Acceptable physical condition and laboratory value
排除标准
- •Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures, Received > 3 total prior therapies for mCRPC., Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of < 60 days used as bridging for lutetium-177 is permitted., Another hematologic or solid tumor = stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy = 2 years from first dose of study treatment. Participants who had curative therapy for localized malignancy are eligible, Untreated, symptomatic central nervous system (CNS) metastasis, Prior treatment with any B7-H3 targeted agent for cancer, Contraindications to the use of corticosteroid treatment, Prior stem cell, tissue, or solid organ transplant, Use of products that have published anti-prostate cancer activity or are known to decrease PSA., Participants with a known history of BRCA mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
研究者
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