2025-520927-26-00招募中3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of JNJ-78278343, a T-cell-redirecting Agent Targeting Human Kallikrein 2 Versus Placebo for Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 247
- 试验地点
- 58
- 主要终点
- Overall survival
研究概览
简要总结
To determine if pasritamig + BSC compared to placebo + BSC is superior in OS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed NE carcinoma, large cell NE carcinoma, or sarcoma of the prostate is disallowed.
- •Hematologic Values Participants should have: - ANC ≥1.0 x 109/L. - Hemoglobin ≥8.0 g/dL. - Platelet count ≥75 x 109/L Note, transfusion or growth factor usage within 28 days of randomization is not allowed.
- •mCRPC: Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening. Local-regional invasion (rectum, bladder) can be included.
- •PSA ≥2 ng/mL at screening.
- •In the opinion of the investigator, the next best treatment option is a clinical trial.
- •Prior Therapy Requirements Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: ARPI: Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI. Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: a) Cabazitaxel is not available. b) The participant’s physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance. Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Radioligand therapy: Should have been previously treated with at least 1 dose of PSMA-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: a) PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. b) The participant’s physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. PARPi: Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available.
- •Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase.
- •Have an ECOG performance status of 0 to
- •Renal Function . Have an eGFR ≥30 mL/min, calculated with the CKD-epi formula, before randomization. Participants with obstructive uropathy should have treatment prior to randomization (eg, foley catheter, nephrostomy tubes, etc).
- •Hepatic Function Participants are eligible if they have the following values: - ALT and AST ≤5 ×ULN. - Serum total bilirubin ≤3 x ULN
排除标准
- •Venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤2) deep vein thrombosis is not exclusionary.
- •Active autoimmune disease within the 12 months prior to signing consent that quires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus).
- •Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 L/min by nasal cannula) to maintain adequate oxygenation.
- •Participant has a prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- •Any of the following within 6 months prior to first dose of study treatment: - Myocardial infarction - Severe or unstable angina - Clinically significant ventricular arrhythmias - Congestive heart failure (New York Heart Association class II to IV) - Transient ischemic attack - Cerebrovascular accident
- •Prior treatment with any CD3-directed therapy.
- •Received immunosuppressive doses of systemic medications, such as glucocorticoids (doses >10 mg/day prednisone or equivalent) within 3 days prior to the first dose of study treatment. A single course of glucocorticoids is permitted as prophylaxis for imaging contrast (ie, for participants with allergies to contrast). If glucocorticoids were used to treat immune-related adverse events associated with prior therapy, ≥7 days must have elapsed since the last dose of corticosteroid.
结局指标
主要结局
Overall survival
Overall survival
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (58)
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